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Medidata have been redefining what’s possible in clinical trials for over 20 years.

Only Medidata combines the wealth of data, AI-powered insights, and patient-centric solutions required to bring tomorrow’s breakthrough therapies and devices to life, and into the hands of patients.


BIOVIA Biopharma Quality Management Analyst Solutions

The pharmaceutical supply chain faces ongoing challenges, with the FDA issuing over 130 recalls in 2022 due to quality issues exacerbated by the pandemic. Biopharma companies are turning to digital quality management solutions to address compliance and overall product quality. Download to find out how.

Integrated Quality Management System

A biopharmaceutical firm encountered difficulties due to isolated documentation and manual entry errors in their quality management system. To address these issues, they implemented BIOVIA’s Biopharma Quality Management Analyst (BQM), a Software as a Service (SaaS) solution seamlessly integrated with the 3DEXPERIENCE® platform. Learn how with this use case.

Connecting Patient-level Clinical Trial Data to Real World Data

Clinical development teams are under continual pressure to create faster and safer interventions for increasingly complex diseases. Historically, regulators have relied solely on clinical trials to prove effectiveness and safety. Although clinical trials provide robust views of outcomes specified within study protocols, they are not always representative of the broader populations that exist in the real world. This means that the results of a clinical trial may vary across patient populations seen in routine clinical practice. Recent investigations into novel conditions such as Vaping Associated Pulmonary Injury or the intense speed of COVID-19 vaccine emergency use authorizations (EUA) have highlighted the need to bridge key evidence gaps in our existing clinical processes. Sponsors have started to bridge evidence gaps by connecting real world data (RWD) sources like electronic medical records (EMR), insurance claims, wearable devices, and genomics to clinical trials in order to understand real world outcomes. In response to this growing trend, regulators have passed key legislation and issued guidance to support RWD usage in regulatory decision making. Now, sponsors have a clearer path forward in using linked RWD and clinical trial data (CTD) at the patient-level to aid in regulatory decision making. These once disparate data sources can be combined to more holistically describe a patient’s healthcare journey. With innovative data linkage technologies like tokenization, researchers are beginning to gain a deeper understanding of patients’ diseases, treatments, and outcomes to close critical evidence gaps. Data linkage unlocks a new frontier in evidence generation where sponsors can finally monitor long-term safety, track patients lost to follow up (LTFU), improve commercial forecasting, and better demonstrate treatment effectiveness. Download to find out more.

The Rise of Integrated Data in Medical Devices

The generation and analysis of massive amounts of data have completely transformed several industries, and this trend will likely continue, revolutionizing almost every facet of the economy. Indeed, a recent analysis concluded that roughly 50% of the S&P 500 will be replaced over the next 10 years, which are “shaping up to be the most potentially turbulent in modern history” (Anthony, 2016). This analysis also showed that over the past 6 years, at least several companies that are heavily reliant on big data analytics entered the S&P 500 (e.g. Facebook, Netflix, and Trip Advisor) (Anthony, 2016). This revolution has largely been driven by ever-increasing computing power at less cost (as per Moore’s Law), coupled with precipitous drops in data storage costs. Additionally, there has been a dramatic uptick in consumer-generated data, and the rise of the platform economy which is broadly characterized by services that act as an intermediary to bring together groups of users to facilitate economic or social exchange (Simon, 2013; Evans, 2016). The prevalence of large datasets (i.e. big data) is providing a resurgence for the field of statistics. While much of the analyses being used today were discovered in the beginning to the middle of the 20th century, over the last decade, innovative artificial intelligence processes have emerged that are superior to the traditional statistical approaches. These advanced techniques are increasingly being used for data integration purposes, whereby heterogeneous data can be acquired, combined and incorporated into a structure that allows different data types. For instance, in the clinical trial industry, this approach can allow for traditional clinical trial data, electronic health records, imaging data, sensor data, and patient-provided data to be merged and utilized for a variety of purposes. We have only scratched the surface in terms of the impact that integrated data analyses will have for commercial purposes. Download to find out more.

The Roadmap to Clinical, Regulatory, and Commercial Success in Medical Device Clinical Trials

Over the past two decades, digital technology has transformed almost every industry and altered the nature of daily life at an incredible pace. In the highly regulated medical device industry, companies eyed digital strategies cautiously as they emerged. The COVID-19 pandemic exacerbated the challenges that medical device clinical trials always faced, including finding a regulatory pathway, managing disparate data sources, and reaching commercial success. A number of factors have applied significant pressure on medical device manufacturers to adopt cutting-edge eClinical technology systems to create more efficiencies and to effectively manage clinical trial data. These factors include an increased push toward decentralization of clinical trials and use of advanced analytics, continued fragmentation of clinical trial data collection, and ongoing and significant changes in the international regulatory environment. Although technology may not resolve all issues regarding medical device clinical trials, many new tech approaches can help medical device companies achieve clinical, regulatory, and commercial success with greater efficiencies, adherence to timelines, and cost savings. Download to find out more.

The Regulatory Evolution and Data Revolution in Medical Device Development

The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. The regulatory environment is continuously changing. Change is driven by globalization, accelerated advancements in science and technology coupled with an ability to advance cures for patients, improve patient safety leading to avoidance of unnecessary incidents. There is an ongoing rise in the sophistication and demands of patients, consumers and regulators. As patients’ and consumers’ expectations evolve, they are demanding a more patient-centric experience and more information shared regarding their conditions and treatments. Trial participants will be seen as collaborators in clinical research rather than subjects. The life sciences and healthcare industries are going through a period of unprecedented regulatory change impacting pharmaceuticals, medical devices, in-vitro diagnostics and healthcare organizations for the benefit of patients. The ability to respond to regulatory requirements swiftly, effectively and efficiently is vital to both a company’s reputation and viability commercially. The transition from current requirements to new requirements can be challenging, especially for companies with disparate systems and data sets that are siloed and now need to be aligned and aggregated. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope of this paper. Medidata looked at some of the themes of which management of medical device data is critical to driving insights and accelerated product development driving innovation and treatments for patients and consumers. Download to find out more.

Breaking Barriers in Medical Device Development: The Convergence of Data and Regulatory Compliance

The life sciences and healthcare sectors rank among the world's most tightly regulated industries, with a regulatory landscape that is constantly evolving. Globalization, rapid advances in science and technology, and the drive to improve patient outcomes and safety have fueled ongoing changes. Patient and consumer expectations are becoming increasingly sophisticated and demanding, with a greater emphasis on personalized, patient-centric experiences and the sharing of information about conditions and treatments. In clinical research, trial participants are now viewed as collaborators rather than mere subjects. Adapting to new regulatory requirements is crucial for companies' commercial viability and reputation, and the ability to respond quickly and efficiently is vital. However, the transition can be challenging, especially for companies with fragmented systems and siloed data that now need to be aligned and integrated. This paper focuses on the ever-changing regulatory environment in the medical devices industry and the corresponding obligations that medical device organizations must comply with. Although the in-vitro diagnostics (IVD) sector has also undergone significant regulatory changes, it falls beyond the scope of this paper. Medidata has identified several key themes in managing medical device data that are crucial to advancing product development, driving innovation, and improving treatments for patients and consumers. Download to find out more.

Rethinking Your Imaging Strategy

Most people involved in medical imaging are aware of the recent upheavals in the industry. Sponsors know that changes to their key Imaging relationships may be imminent. Anticipating these changes and properly handling them may well have an impact on your trial. The current state of the clinical trial imaging industry can best be described as murky and unsettling and could put your timelines at risk. The wave of M&A activity across key imaging players has created confusion and a lack of transparency directly impacting sponsors and sites. The new mergers, acquisitions, and partnerships are causing disruptions across technology, process, and people. This guide is designed to help you avoid the pitfalls in this disrupted landscape. Across eight parameters, learn how you can regain control of your Imaging strategy and leap ahead in the transformation of imaging for your trials. Download to find out more.

Medidata DCTs – The Patient Perspective

Often patients who want to be proactive about treatments for their conditions will seek out medical trials. Unfortunately, there are a number of stumbling blocks which might prevent someone from finding the right trial for them. If a patient has to travel particularly far to get to the relevant clinic, or they don't feel like the procedure of a trial has been effectively communicated with them then they may be put off the idea. Watch this short video to see how myMedidata helps to make clinical trials more accessible and easier to manage for patients.

Medidata DCTs – The Site Perspective

Clinical trials have the potential to take up a lot of time for doctors, who also have to find a way to see to their regular patients. Doctors would benefit from one universal system which allows them to screen potential trial participants, meet them virtually and track their progress throughout the trial. Watch this short video to see how myMedidata offers a platform which ticks all of these boxes and provides a consistent, simple solution to running clinical trials.

Medidata DCTs – The Sponsor Perspective

Sponsors running clinical trials want to provide both patients and sites with the best experience possible when conducting trials. Medidata offers a service where all users are on the same platform, making the process of collecting and analysing data straightforward. It also serves to aid with faster patient enrolment, as well as helping to include patients from under-represented communities. Watch this short video to find out more about how Medidata helps to offer the best possible service for sponsors, patients and clinics.

Making Clinical Research Better for Patients with Patient Centricity by Design

Patient centricity emphasizes prioritizing patients' experiences and outcomes, yet a universally accepted definition and standardized approach for patient-centric trials remain elusive. Many sponsors struggle to integrate patient and caregiver perspectives effectively into trial designs. While techniques like advisory boards and digital tools capture patient insights, they often lack a systematic approach, leading to inconsistent patient engagement and trust erosion. At Medidata, we introduced Patient Centricity by Design (PCbD) to embed patient-centric principles into our clinical research software, inspired by the concept of privacy by design. Download to find out more.

Shorten the Path From Discovery to Approval of Novel Therapies

The competitive race to develop and launch new therapies faces challenges, including lengthy timelines, increased costs, and low drug approval rates despite rising R&D spending. Organizations can leverage external evidence, such as real-world data (RWD), to improve outcomes. However, RWD may introduce biases and lack specificity. Medidata Trial Design offers access to extensive clinical trial data from over 30,000 trials and 9 million patients, paired with advanced analytics and industry expertise. This enables clinical development teams to enhance trial planning, increase regulatory success probabilities, accelerate market entry, reduce risks, and minimize patient burden. Download to find out more.

4 Ways To Increase Diversity in Clinical Trials

Lack of diversity in clinical trials has been a long-standing issue, and one with extensive implications. It can not only create gaps in the industry’s understanding of how treatments in certain disease areas affect minority participants, but also lead to inequitable access to novel treatments. Unfortunately, increasing diversity in clinical trials has been historically difficult due to barriers for sponsors and CROs, sites, and patients. By keeping diversity at the forefront of every step in the clinical trial process, it is possible to address these barriers early on to support a successful and equitable clinical trial. With this eBook, sponsors and CROs will learn the steps they can take to build diversity strategies that: - Incorporate diversity into every step of the trial lifecycle - Create an experience designed for patients with trusted community partners - Set trials up for regulatory and operational success - Bridge the diversity gap with enhanced accessibility to information and sites Download to find out more.

6 Data Linkage Use Cases to Future-Proof Your Clinical Trial

Clinical trials are essential for medical regulatory decisions, but trial patients also generate valuable real-world data (RWD) through interactions with healthcare systems. This RWD, including medical records and wearable device data, complements clinical trial data (CTD) to offer deeper insights into treatment benefits, risks, and costs. Historically, concerns over patient privacy have hindered the integration of clinical trials and RWD, delaying access to vital data and insights. However, new tokenization technologies are bridging this gap, allowing sponsors to link CTD with RWD at the patient level. This integration provides a more comprehensive view of patient trajectories and outcomes, addressing critical evidence gaps and enabling new applications in patient tracking, treatment effectiveness, and long-term safety monitoring. Medidata Link offers a centralized solution for connecting patient-level CTD and RWD across multiple research sites. Integrated with the Medidata Clinical Cloud platform, it ensures secure data management, compliance, and scalability. Features include: - Scalable PII ingestion for centralized processing of personally identifying information. - Secure data management with industry-leading tokenization, ensuring patient privacy. - Continuous evidence generation through various use cases, with options for further analytics through Medidata AI. Download to find out more.

Busting the Top 7 Data Quality Myths in Clinical Trials

In recent years, clinical trial data collection has shifted dramatically due to technology. The industry now boasts diverse data sources, expected to grow as trials integrate new devices and patient participation methods. This shift has led to industry-wide efforts to integrate data, improve sharing, and reduce silos. Medidata's analysis shows that while electronic case report form (eCRF) data volume remains steady, its proportion to total clinical trial data is decreasing. The COVID-19 pandemic accelerated remote data collection methods, replacing traditional in-person approaches. Despite pandemic challenges, the industry has innovated and adapted, emphasizing patient-centered strategies. Yet, the data abundance poses operational questions on effective management. This white paper clarifies the evolving clinical data landscape, debunking myths and addressing challenges. Download to find out more.

Transforming Clinical Operations: Data and Advanced Analytics to Power Action Across the Trial Continuum

Clinical operations play a critical role in the planning, execution, and management of a clinical trial, from study design and planning to successful study start-up and execution, to final study close out. As the complexity of clinical trials and data collection increases, clinical operations must keep pace to meet regulatory requirements, patient safety, and trial timelines. Traditional approaches which rely on point solutions and siloed analytics are no longer fit-for-purpose, resulting in inefficient data re-entry and delayed insights. Today’s study teams need more intelligent feedback from the technology they use, and in turn they are asking more of technology partners. Today’s users must be empowered with user-friendly technology that reduces clicks, increases access to data insights, and orchestrates end-to-end workflows that cross traditionally siloed systems Download to find out more.

Rave eTMF – Simplify Trial Oversight with Unified Document Management

Your Trial Master File (TMF) complexity is growing. It’s not uncommon to upload thousands of documents per day, subject to strict regulatory requirements for filing, and under aggressive timelines. It is paramount that a robust and reliable electronic TMF (eTMF) is constantly inspection-ready, provides accessible metrics for monitoring, and favors collaboration between sponsor, CRO, and site systems. Download to find out more.

Rave CTMS – Comprehensive Trial Management Powered by Data

Optimized clinical trial operations is a key differentiator for delivering high quality treatments to patients, on time and on budget. Companies with robust processes and technologies for study start-up, monitoring oversight activities, risk management, and sound document management can quickly adjust to the complexity resulting from the ever-changing clinical trial development landscape. At the center of all these technologies is a dynamic, modern clinical trial management system (CTMS). Download to find out more.

Medidata Detect: Ensure Quality With Comprehensive Data Surveillance and Risk Monitoring

Oversight of data quality and patient safety during a clinical trial is a team effort. The explosion of novel ways to collect and monitor on-site and remote data provides opportunities to uncover valuable insights during clinical research. However, it also increases the complexity and pressure on operational teams to support and scale these new approaches. Too often, siloed working groups and systems prevent timely identification and correction of quality issues, negatively impacting trial timelines and operational costs. Download to find out more.

CDS: Marketing Mix Models

Marketing mix models are leveraged to assess the impact of multiple promotional channels within a company or brand on their return on investment or ROI. Bayesian regressions combined with nonlinear transformations and ad stock decay are the common marketing data models of choice. But as the data landscape rapidly shifts with technology-driven advances such as AI and automation, the ability to choose the best algorithm in real-time grows more challenging. Download to find out more.

Intelligent Trials: Diversity in Clinical Trials

Diversity in clinical trials has been a long-standing issue across clinical research. Studies have historically failed to represent the patient population, with the majority of patients enrolled in trials being White, younger men. This has caused not only gaps in the industry’s understanding of how treatments in certain disease areas broadly affect diverse populations, but also inequitable access to treatments. As a result, lack of representation can also impede healthcare decision-making and future clinical development. Download to find out more.

Outsource Your Site Payments While Retaining Full Financial Visibility and Control with Medidata

Clinical trials are expensive, and managing the finances of these trials can be a challenge. One of the biggest challenges is managing site payments. This can be a time-consuming and complex process, and it can be difficult to ensure that payments are made on time and accurately. Medidata Rave Site Payments Managed Services can help you to outsource your site payments while retaining full financial visibility and control. With Rave Site Payments Managed Services, you can: • Automate your site payment process: Rave Site Payments Managed Services automates the entire site payment process, from invoicing to reconciliation. This can save you time and money, and it can help to reduce the risk of errors. • Improve your financial visibility: Rave Site Payments Managed Services provides you with real-time visibility into your site payment data. This allows you to track payments, identify potential problems, and make informed decisions. • Retain full control: With Rave Site Payments Managed Services, you retain full control over your site payments. You can approve payments, make changes to invoices, and access all of your data at any time. If you are looking for a way to outsource your site payments while retaining full financial visibility and control, Rave Site Payments Managed Services is a great option. Contact us today to learn more about how we can help you.

GRANTS MANAGER – Infographic

Rave Grants Manager: A Comprehensive Solution for Investigator Grant Management Clinical trials are expensive, and securing funding is essential for their success. However, the investigator grant management process can be complex and time-consuming. This is where Rave Grants Manager comes in. Rave Grants Manager is a comprehensive solution that provides sponsors and CROs with a single platform for managing all aspects of investigator grant management. This includes: • Budget planning • Negotiation • Tracking • Reporting In addition to these features, Rave Grants Manager also offers a number of benefits, including: • Increased efficiency • Improved accuracy • Reduced risk • Improved compliance If you are looking for a comprehensive solution for investigator grant management, Rave Grants Manager is a great option. Contact us today to learn more about how we can help you.

Rave Grants Manager Fact Sheet

Rave Grants Managers manages the entire investigator grant life cycle of clinical trials. The solution provides Sponsors and CROs with a comprehensive, data-driven way to quickly and accurately develop investigator grant budgets, efficiently conduct the site budgeting process, and leverage tools and data to process site budget amendments. Download to find out more.

Data-Powered Financial Management for Your Clinical Trials

Achieve complete financial visibility, eliminate complexity, and ensure the financial health of your clinical trials with Rave Clinical Trial Financial Management (CTFM). MAKE SMARTER AND FASTER FINANCIAL DECISIONS Medidata Rave Clinical Trial Financial Management (CTFM) pairs Rave Grants Manager Planning and Contracting with Rave Site Payments, to power Sponsors and CROs with an end-to-end financial management solution. From study budget planning, to site budget negotiations and site payments, CTFM ensures financial visibility throughout your entire study life cycle. • Improve operational efficiencies • Empower data-driven decisions • Gain full financial transparency • Shift focus back to patients VIEW THIS INFOGRPAHIC TO LEARN MORE

Moderna’s COVID-19 Vaccine Clinical Trials Supported by the Medidata Clinical Cloud

Moderna's COVID-19 vaccine clinical trials were supported by the Medidata Clinical Cloud, a cloud-based platform that provides a single environment for managing all aspects of clinical trials. The Medidata Clinical Cloud was used to: • Automate clinical trial workflows: The Medidata Clinical Cloud automated many of the manual tasks involved in clinical trials, such as data entry, data management, and reporting. This helped to improve the efficiency and accuracy of the trials. • Improve communication and collaboration: The Medidata Clinical Cloud provided a centralized platform for communication and collaboration between all stakeholders in the clinical trials, including sponsors, CROs, investigators, and patients. This helped to ensure that everyone was on the same page and that the trials were conducted smoothly. • Ensure compliance with regulations: The Medidata Clinical Cloud is compliant with all applicable regulations, which helped to ensure that the clinical trials were conducted in accordance with the law. The Medidata Clinical Cloud played a critical role in the success of Moderna's COVID-19 vaccine clinical trials. By automating clinical trial workflows, improving communication and collaboration, and ensuring compliance with regulations, the Medidata Clinical Cloud helped to accelerate the development of a safe and effective vaccine that has saved millions of lives. Contact us today to learn more about how we can help you.

Medidata Patient Data Surveillance

Automate and Accelerate Clinical Data Management Activities Medidata Patient Data Surveillance is the latest innovation to Rave EDC, combining two powerful data management solutions. The first solution is Patient Profiles which enables intuitive safety and medical reviews. The second solution is Data Reviewer, which aggregates patient data from almost any source for review, interrogation, and reconciliation, all from a single location. VIEW PATIENT DATA SURVEILLANCE FACT SHEET

Automated Clinical Trial Monitoring Workflows Make a Lean Team More Efficient

The Challenge: Burdensome Manual Letter and Report Creation Until 2019, Enterin’s clinical monitoring team manually created reports, confirmation letters, and follow-up letters. “Generating the letters and reports was cumbersome, and took 5-6 hours a week away from site monitoring,” says Lisa Lutz, senior manager for clinical monitoring at Enterin. Personnel spent more time manually tracking site visits on a spreadsheet. To increase efficiency, Enterin wanted to automate the generation of letters and reports, automatically notify clinical research associates (CRAs) and other stakeholders when site visits were due, and make it easier to share data with senior leadership and site managers. Read this case study to learn more about the solutions and benefits!

A Top 10 Pharma Company Doubles High-Performing Site Count in a Priority Indication with Medidata AI Intelligent Trials

As a top 10 biopharmaceutical company embarked on clinical trials, it wanted to identify new Tier 1 sites and gain insight into the performance of its existing sites. This in-depth case study explores how Medidata AI integrated cross-industry clinical trial data with the company’s data to more than double its list of high-performing sites. While reading, you’ll learn more about: • The challenges the company faced • The benefits of Medidata AI data compared to publicly available data • What advantages the company unlocked with Medidata AI Use Medidata AI’s data to reimagine clinical trial site selection for your business.

The State of Black Participation in Clinical Trials

Improving diversity in clinical trials is not just the right thing to do, it is necessary for better science, more representative outcomes, and increased health equity. Historically, clinical trials have been shown to recruit disproportionately large percentages of White participants. These skewed participant populations raise concerns about the generalizability of trial results to underrepresented non-White participants and inequitable access to clinical trial treatments. The FDA published updated guidance to address these concerns in April 2022, stating that clinical trial participants need to reflect the demographic distribution of the United States (US) population. Download to find out more.

6 Data Linkage Use Cases to Future-Proof Your Clinical Trial

Clinical trials remain the gold standard for regulatory decision making in medicine. However, patients who participate in clinical trials continue generating a wealth of real-world data (RWD) in their interactions with the larger healthcare ecosystem before, during, and after a trial. Trial patients’ RWD, such as medical claims, electronic medical records (EMR), registry data, and wearable device data, that are routinely collected in the background can supplement active collection of clinical trial data (CTD) and provide a substantially deeper insight on benefits, risks, and cost of treatments

Integrated Evidence Success Stories and Partnerships

Teams know there is real world data that could generate evidence to inform study design, ease recruitment, or drive medical engagement. However, finding the relevant data and generating insights can be challenging. Until now. Integrated Evidence connects historical data from more than 20,000 cross-sponsor clinical trials and 6 million patient volunteers, with real world data, to deliver powerful insights and the necessary evidence clinical development leaders need to increase the probability of trial success. In this e-book, you will find out how Integrated Evidence can resolve the challenges of clinical trial data availability and ensure that the data is of regulatory-approved quality.

The Digital Model for Clinical Research

The biopharma industry constantly innovates to bring crucial therapies to patients, and this spirit of innovation has propelled the adoption of digital technologies for clinical trials. Large sponsors, during the past twenty years, have implemented digital technologies to connect clinical trial workflows, derive superior value from clinical and real-world data, and manage critical processes like study planning and regulatory submission.

FAQs to Guide Your Decentralized Clinical Trials Strategy

Decentralized trials, also known as hybrid trials, virtual(ized) clinical trials, remote trials, and directto-patient trials, employ a method of conducting clinical trials where parts or all of the trial happen outside a traditional physical clinic or trial site.

Five Quick Tips to Accelerate Your Study Build

Accelerating study build times became an imperative during COVID-19. Delivering faster study builds has since propelled the adoption of new technology, processes, and resources. Study build teams are required to simplify and future proof design to save downstream time and costs. They also have an opportunity to gain greater control of study data and execution, optimize the entire trial lifecycle, and accelerate time-to-market. While speed prevails, study build teams need to ensure study integrity, patient safety, and regulatory requirements. The technology strategy they choose, the approach they take, and the specialists they partner with drive the pace, data integrity, and successful outcomes of their trials. This eBook outlines five specific tips you can apply to accelerate and optimize your study builds today, and into the future.

Synthetic Control Arm®: The Regulatory Grade External Control Arm to Power your Clinical Trials

Although Randomized Control Trials (RCTs) play a vital role in assessing the safety and efficacy of new treatments, sometimes it is not possible to maintain a concurrent control arm. Thankfully, External Control Arms (ECAs) can provide a solution, enabling sponsors to address recruitment challenges in trials and offering additional data to improve trial results. In this eBook, you will learn about: • The growing importance of ECAs • The differences between control groups built with real world data (RWD) and a Synthetic Control Arm (SCA®) leveraging historical clinical trial data (HCTD) • How SCA impacts clinical trial design decisions Read on to uncover the compelling benefits of ECAs.

8 Strategic Questions to Help Determine Your Path to Decentralization

In this eBook, we’ve compiled eight strategic questions that will help jumpstart your path to decentralized clinical trials (DCTs), explaining what qualifies as a decentralized clinical trial, what decentralizing technology means for study teams, and how decentralization benefits patients, sites, and sponsors. Let’s start with the basics.

Unlock the Value of Your Clinical Trial Data and Content with Big Data Discovery

From leisure activities, to our own health and wellness, to the industries in which we work — Big Data has transformed our world. Subscription-based content providers, like Netflix and Amazon Prime, are changing television programming by using detailed customer segmentation and viewing habits to rethink how new programming is funded, produced, and released to the market. Everyday items like Nest are transforming home heating and cooling by collecting and aggregating sensor data to automate thermostat changes. In the clinical research industry, the creation and availability of many more data points is changing everything too. Historically, data came from a single source: a patient visiting a clinic, whose information would be entered into an electronic data capture (EDC) system. Today, clinical trials are accommodating an incredible variety of data and content sources: from traditional clinical data, to high resolution images, to genomic and wearable sensor data, investigator files, consent forms, and much more. This data explosion brings new and transformative opportunities, but it also comes with additional risks

Synthetic Control Arm® in Clinical Trials

While randomized controlled trials (RCTs) are the gold standard for evaluating the safety and efficacy of new medical treatments, maintaining a concurrent control arm is sometimes not feasible and can lead to increased patient burden and threaten the completion of a trial. Such uncontrolled trials are commonly conducted in rare, orphan, or very serious drug indications, when there is a shortage of patients or investigational drug, when there are scientific concerns about treatment switching/crossover, or for ethical concerns. In such cases, sponsors rely on study designs that deviate from the traditional RCT, such as single-arm trials, which can yield important safety and efficacy data that can support a regulatory submission and have recognized benefits, such as smaller sample sizes, the ability to end quickly if a drug has low activity, and that all (or at least most) patients receive the investigational drug (Grayling, 2016). However, uncontrolled trials also risk generating biased data because of a lack of randomization. To overcome these challenges, sponsors sometimes employ external controls; these improve the interpretation of single-arm trials, by providing supportive evidence that is highly contextual and would otherwise be absent, and also allow sponsors to better understand their trial population if patients were not on therapy. While there are several available external control options, the accumulation of vast amounts of patient-level data is enabling higher-quality and more informative external control arms. This white paper discusses the concept of the Synthetic Control Arm® (SCA®),1 which is a type of external control that is generated using patient-level data from patients external to the trial with the goal of improving the interpretation of uncontrolled trials, which can enable better product development decisions. A series of case studies are provided to highlight the different ways an SCA has been used.

Clinical trials are better, faster, cheaper with big data

Clinical trials have never been more in the public eye than in the past year, as the world watched the development of vaccines against covid-19, the disease at the center of the 2020 coronavirus pandemic. Discussions of study phases, efficacy, and side effects dominated the news. The most distinctive feature of the vaccine trials was their speed. Because the vaccines are meant for universal distribution, the study population is, basically, everyone. That unique feature means that recruiting enough people for the trials has not been the obstacle that it commonly is. “One of the most difficult parts of my job is enrolling patients into studies,” says Nicholas Borys, chief medical officer for Lawrenceville, N.J., biotechnology company Celsion, which develops next-generation chemotherapy and immunotherapy agents for liver and ovarian cancers and certain types of brain tumors. Borys estimates that fewer than 10% of cancer patients are enrolled in clinical trials. “If we could get that up to 20% or 30%, we probably could have had several cancers conquered by now.” Clinical trials test new drugs, devices, and procedures to determine whether they’re safe and effective before they’re approved for general use. But the path from study design to approval is long, winding, and expensive. Today, researchers are using artificial intelligence and advanced data analytics to speed up the process, reduce costs, and get effective treatments more swiftly to those who need them. And they’re tapping into an underused but rapidly growing resource: data on patients from past trials.

Direct-to-Patient Clinical Trials

Drug development is a risky endeavour that is expensive, complex, and lengthy. A significant portion of resources earmarked for drug development programmes are consumed by screening, recruiting, enrolling, engaging, monitoring, and retaining patients in clinical trials. The pharmaceutical industry is continually exploring novel trial designs and methods that may alleviate the high costs and shorten study times, which can ultimately expedite new medicines to market. In clinical trials, the Direct-to-Patient (DtP) model allows for study medications to be received and administered in a patient’s home rather than a clinical site. The DtP drug supply model has gained momentum in recent years and continues to evolve since it can confer valuable benefits to sponsors and patients. This white paper provides an overview of the factors that drive the rapidly evolving clinical trial design landscape and demonstrates how DtP trials can solve some of the difficulties facing drug sponsors today, including common pitfalls to consider when embarking on a DtP trial. Download this white paper today.

Synthetic Control Arm® in Clinical Trials

While randomized controlled trials (RCTs) are the gold standard for evaluating the safety and efficacy of new medical treatments, maintaining a concurrent control arm is sometimes not feasible and can lead to increased patient burden and threaten the completion of a trial. Such uncontrolled trials are commonly conducted in rare, orphan, or very serious drug indications, when there is a shortage of patients or investigational drug, when there are scientific concerns about treatment switching/crossover, or for ethical concerns. In such cases, sponsors rely on study designs that deviate from the traditional RCT, such as single-arm trials, which can yield important safety and efficacy data that can support a regulatory submission and have recognized benefits, such as smaller sample sizes, the ability to end quickly if a drug has low activity, and that all (or at least most) patients receive the investigational drug (Grayling, 2016). However, uncontrolled trials also risk generating biased data because of a lack of randomization. To overcome these challenges, sponsors sometimes employ external controls; these improve the interpretation of single-arm trials, by providing supportive evidence that is highly contextual and would otherwise be absent, and also allow sponsors to better understand their trial population if patients were not on therapy. While there are several available external control options, the accumulation of vast amounts of patient-level data is enabling higher-quality and more informative external control arms. This white paper discusses the concept of the Synthetic Control Arm® (SCA®),1 which is a type of external control that is generated using patient-level data from patients external to the trial with the goal of improving the interpretation of uncontrolled trials, which can enable better product development decisions. A series of case studies are provided to highlight the different ways an SCA has been used.

Electronic Informed Consent in Clinical Research

Medidata is conducting a study to understand the regulatory positions, adoption and the variability regarding electronic informed consent (eConsent) around the world. This exercise has come about due to the extensive number of regulatory relevant enquires Medidata gets from sponsors and organisations managing trials in research. These organisations are keen to have the option to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to seek clarity on this topic was to directly engage with the relevant bodies. The study initially focused on the countries in the European geographic region countries but has evolved to other regions including Asia Pacific and the Americas. The study prioritized countries where there was an aspiration to run electronic informed consent by organisations running clinical trials. Throughout the study, Medidata has directly engaged with regulators, health authorities and ethics groups to assess the eConsent landscape. Overall, the Medidata study team has collected meaningful feedback and engaged in positive and encouraging dialogues with these organisations. However, almost half of the bodies Medidata contacted have not responded or did not fully respond to the question being asked. We deduce this may be due to a lack time to consider the topic and/or a lack of general position. The patient-centric benefits of electronic informed consent technologies have been well documented.1,2 Electronic informed consent has led to improved patient engagement and the ability to obtain trial patient signatures electronically whilst personally identifiable information (PII) remains safe and securely stored. The US Food and Drug Administration (FDA) provides non binging recommendations on the subject and the US has seen accelerated adoption of eConsent solutions. Subsequently, the UK regulator, the MHRA (Medicines and Healthcare Regulatory Agency) has also issued a very comprehensive guidance and is exemplary in the thought leadership in terms of the interplay of eConsent and the consideration of the multiple EU regulations and UK laws. The EU has seen variable adoption, mostly due to a lack of regulatory clarity and operational reasons. It is good to note that new EU eSystems guidance is being written to include electronic informed consent.

Decentralized Clinical Trials: The Future of Clinical Research Is Here

Improvements in technologies and methods to drive clinical trial innovations have focused on the incorporation of decentralised clinical trials (DCTs) - also sometimes referred to as ‘remote’, ‘hybrid’, ‘virtual’ or ‘patient-centric’ trials. The COVID-19 pandemic has significantly accelerated the adoption of DCTs, which allowed sponsors to quickly virtualise many trial activities, including remote monitoring, telehealth visits, electronic consent (eConsent), electronic patient reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), and use of wearables/sensors. The uptake in DCTs is expected to continue in a post-COVID-19 world due to the experience gained during the pandemic The DCT trend is being driven by several headwinds that have converged, including the COVID-19 pandemic, ballooning drug development costs, and a greater focus on the patient-centricity and value demonstration of new therapies. Clinical trials are currently evolving and becoming modernised as they continue to integrate more and more virtual elements. Sponsors must prepare themselves for this increasingly digital future, which will demand scalable, flexible, interoperable, unified, and intelligent software platforms to synthesise patient-centric data into real-time insights that will offer benefits to stakeholders across the healthcare spectrum. This white paper provides an introduction to DCTs and summarises the state of the industry from the perspective of different stakeholders, including the pharmaceutical and medical device industries, regulators across the world, and patients.

Decentralized Clinical Trials

With more data being collected directly from patients, either via wearable devices and sensors, electronic clinical outcome assessment (eCOA), and/or telehealth platforms, there is an urgent need to shift our thinking from reactive strategies into proactive planning and technology-based solutions to replace the query and listing-based reviews of trials past. The challenge for those in Data Management leadership and those working directly on trials themselves is how best to incorporate an ever-increasing list of data sources, novel data types, and analytic tools executing the core function of Data Management - ensuring that the clinical data collected is fit for purpose. This white paper explores how Data Management can be better equipped to provide engagement from protocol design, to data visualisation development and patient-centric technology solutions in any phase of a decentralised trial.

Modernizing Clinical Trial Oversight: The Path to Clinical Operations Excellence

The rising complexity of clinical trials, combined with pressures resulting from the COVID-19 pandemic, have forced sites, sponsors, and clinical research organizations (CROs) to adopt remote and risk-based approaches for clinical trial execution to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity. With the increasing prevalence of decentralized clinical trials (DCTs), the industry is now poised to fully embrace and implement risk-based quality management approaches to trial execution and oversight. Despite a decade’s worth of industry dialogue and widespread regulatory acceptance, Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) have not been widely adopted by clinical trial sponsors and CROs. But the rising complexity of clinical trial protocols, the increase in the types and volume of patient-centric data, and the challenges of the COVID-19 pandemic - limits to on-site activities, in particular - have brought renewed attention and interest to these approaches. Now that risk-based approaches to clinical trial oversight are of greater importance, it is time to renew the conversation around RBQM. Many sponsors and CROs recognized operational efficiencies and improvements in trial execution as a result of the risk-based approaches they took in 2020, and these benefits could continue to accrue long after the pandemic is over. In this paper, Medidata outlines the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.

Advancing Decentralized Clinical Trials Through a Unified Approach to eCOA and Digital Health Technologies

What are Digital Health Technologies? According to FDA, Digital Health Technologies (DHTs) are technologies that empower patients to innovatively monitor their health status/well-being and enable providers and other stakeholders to achieve efficiencies, expand access, reduce costs, increase quality and personalize treatments for patients (FDA: What is Digital Health?)1. Examples include wearables, sensors, bluetooth-enabled devices, wireless medical devices, mobile applications, and telehealth solutions. Download to find out more.

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