While assisting clients with their clinical development plans, and post-marketing studies, our team is witnessing a trend in designing RWE studies with both traditional and virtual elements. With growing interest in hybrid designs, Covance is exploring how we can help our clients incorporate their study objectives while evaluating a range of alternative options for evidence generation that enable faster, less resource intensive and more patient-centric, study execution.
In this second article in our series of three, learn how we collaborated with RWE professionals to create a unique RWE framework tool that can help your teams with study planning in today’s rapidly evolving environment.
SEND [Standard for Exchange of Nonclinical Data] is more than just a tool to facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.
Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large focus upon the development of new drugs for the treatment of IBD. While this is undoubtedly a welcome fact for patients and their families, the current level of research activity brings logistical challenges when conducting clinical trials. Continue reading →
Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
In this blog we begin to examine the current issues with traditional electronic data capture systems and other current “big data” approaches that attempt to address complex operational reporting needs in this historically stagnant and underserved area. We also discuss the use of two distinct data repositories – an operational data warehouse and a clinical data warehouse – the Xcellerate® Clinical Data Hub as part of a new data model through the Xcellerate Informatics Suite to provide a significant technological advance in clinical trial operations. Continue reading →
Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end.
Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can understand regulatory differences and identify a fit-for-purpose program. We will also cover how to proactively identify key issues for both PK equivalence and Phase III equivalence studies, and initiate market access and commercialization approaches. Continue reading →
Change is in the Air There’s reason for new hope in the ongoing battle against cancer. From standing-room-only presentations of provocative data at cancer conferences, to landmark publications and new drugs approvals, the signs are multiple and clear. Harnessing the immune system as an anti-cancer therapy–a strategy that has yet to fully deliver on its promise– is now the most exciting area of oncology drug development.
Immune Surveillance: an Invisible Malignancy Sentinel The first chapter in the story of cancer immunotherapy is a tale that provides perspective on how evolving scientific insight serves as a backdrop to the interplay between human hopes and the sometimes capricious nature of medical advances. But that story is well beyond the scope of the next 800 or so words. However, we can take advantage of hindsight to consider some of the key lessons learned. Continue reading →