White Papers

1. Medical Device Development: Pathways To Clearance Or Approval In The U.S. And Europe 11/29/2022

   In this white paper, explore the development process, regulatory landscape, and pathways to approval for medical devices to help sponsors optimize the likelihood of commercial success.

2. Advancing Pediatric Cancer Research 11/23/2022

   Discover how the RACE for Children Act will have significant impact on cancer drug development.

3. Pediatric Oncology Trials: Changes On The Horizon 11/23/2022

   This white paper examines specific considerations and planning for pediatric oncology trials, and the changing landscape in pediatric oncology drug development.

4. Using Electronic COAs/PROs To Capture The Patient Experience 11/16/2022

   As telehealth solutions and mobile health devices help empower decentralized clinical trials, discover how study sponsors look for ways to further improve the patient and site experience while delivering high-quality data.

5. Site Perspectives On Decentralized Clinical Trials 11/15/2022

   Discover why understanding clinical research sites’ experiences and perspectives on DCTs will help industry stakeholders  refine trial design, operational procedures, and regulatory policy to better serve patients and sites.

6. The EU MDR Is In Effect. Now What? 11/15/2022

   In May 2021, the EU MDR replaced the EU's Medical Device Directive and Directive on Active Implantable Medical Devices. Learn about the basics of this regulation, who it impacts, and how to collect EU MDR-compliant clinical data.

7. Guide To Digital Endpoints In Rheumatology Research 11/14/2022

   In rheumatology, learn why both the FDA and EMA have highlighted the need to assess physical function and walking as key efficacy endpoints.

8. Real-World Sleep Assessments Using Wearable Technologies 11/14/2022

   Poor sleep patterns are linked to the progression of many diseases. This white paper explores the advantages of assessing sleep from the patient’s home using wearables.

9. The Future Of Health Data: A 2022 Life Sciences Industry Insights Report 11/14/2022

   A survey of life sciences leaders reveals some of the key challenges that come with using real-world data (RWD) for innovation, along with their vision and predictions for how RWD can accelerate drug development and improve patient outcomes.

10. The State Of Innovation In Europe 11/11/2022

    Discover the current state of innovation in Europe, from pipeline constitution to emerging drug modalities, R&D alliances to financing trends.