• Synthetic Control Arm® In Clinical Trials

    This white paper discusses the concept of the Synthetic Control Arm® (SCA®), 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.


  • Multivigilance In The Cloud

    Manufacturers must monitor how each product they sell performs with real patients as they use it outside the carefully controlled conditions of a clinical study. This process of multivigilance – the management of safety information for different kinds of medicinal products such as drugs, vaccines, medical devices, and combination products – is required throughout the entire product lifecycle. Continue reading to learn how cloud technology makes patient safety less expensive and more efficient.

  • Expediting Path To Clinic With OptiForm® Total Supply

    MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. Learn how Catalent provided integrated formulation development, clinical trial material manufacturing, and supply and distribution services to ensure successful delivery of the kits to MGB's patients.

  • From Liability To Asset: A TMF Rescue

    The company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. During NDA preparations, they discovered that the Trial Master File for these studies was scattered across hundreds of boxes of paper and several hard drives. The document experts at Phlexglobal quickly scoped the project and were convinced they could deliver an inspection-ready TMF in the time allowed – which was fast running out.

  • Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda

    Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.

  • Comparing Continuous And Batch Processing In Downstream Purification

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  • The Michael J. Fox Foundation For Parkinson’s Research Works With Service Provider To Remove Reimbursement And Travel Obstacles For Clinical Study Participants

    In 2010, MJFF launched a large-scale clinical study conducted at a network of clinical sites around the world focused on identifying and validating Parkinson’s disease biomarkers. The study realized it needed a new way to ensure that participants were remaining engaged throughout the long protocol and that the experience was as seamless as possible for both the volunteers and the site coordinators. They were able to source a solution to support patient-centricity, as well as study site efficiency.


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The effort to protect trial participants during a global pandemic led many companies to adopt technologies they had not used in the past. One of those is virtual or decentralized trials. In this collection of articles from Clinical Leader, learn how sponsor companies are adapting to the new normal in clinical trials and reducing risk while creating tomorrow’s new study paradigms.

More Content Collections


  • Best Practices For Implementing Decentralized Clinical Trials

    While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

  • Lessons For Leaders: The Loud And Lasting Impact Of COVID-19 On The Future Of Clinical Research

    Last year, shortly before the pandemic, we predicted that clinical trials of the future would be more open, more human-centered, and more integrated in the healthcare ecosystem, providing guideposts for how industry will adapt along these three themes. COVID-19 has both accelerated these trends and highlighted new challenges for R&D leaders to address.

  • Janssen’s Patient-centric Approach To Psychiatric Disease Management

    Diseases as complex as those of the brain require an equally complex approach, centered on the unique needs, goals, and circumstances of the individual patients, as well as the loved ones who support them. Listening, empathizing, understanding — these basic human interactions will have a critical role in our ability to reach our goal and deliver transformational medical innovations.