Thought Leadership
The Ultimate Clinical Trial Translations Checklist
Clinical product development is an elaborate endeavor executed through a complex web of processes that are in large part accomplished through various document and communication work streams. These work streams can represent a significant source of cost, risk, and time. When a...
CCMS: A Good Fit for Pharmaceutical and Clinical Research Organizations?
Kaarin Gordon discusses the choices and challenges for efficient content reuse facing Pharmaceutical and Clinical Research Organizations. What they want is a set of tools and platforms for easy content reuse, automatic propagation of changes from a single source, and content...
LifeSci Talks COA Series | The Future of Capturing Patient Data in Clinical Trials: DCTs, Site Staff Burden, and Regulation Considerations with Paul O'Donohoe
Mark Wade interviews Paul O'Donohoe, Senior Director of Product for eCOA and COA at Medidata. They delve into the challenges and opportunities of adopting decentralized clinical trials (DCTs) and explore topics such as mixed modalities for data capture, patient burden, site...
Transitioning Clinical Trials Under the EU CTR
The transition from Clinical Trial Directive to Clinical Trial Regulation in Europe adds new requirements and complexities to the clinical development landscape. The required transition of all trials concluding January 1st, 2025 brings about several considerations to ensure...
EU CTR: An Introduction to European Clinical Trial Transparency
Are you looking to stay ahead of the curve in the ever-evolving landscape of European clinical trials? We are thrilled to announce the availability of our newest on-demand webinar, in which we dive deep into the recent changes to the European Clinical Trial Regulation (EU CTR)...
Top 10 Prompts to Ask ChatGPT for Optimizing Clinical Trial Recruitment Strategies
Patient recruitment and engagement are critical to the success of clinical trials. Yet despite the tremendous progress made in drug development, recruitment and retention remain major challenges. Over the last 25 years, the industry has attempted to crack the code; however, 86%...
EU CTR White Paper - Operational Considerations & Challenges
The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness...
Intelligent Automation for MDR & IVDR Content: Summary of Safety & Clinical Performance (SSCP), Summary of Performance (SSP), and Selected Labeling
Content requirements under the EU’s MDR and IVDR, including the translation of labeling, marketing, SSCPs, SSPs, and clinical communications, are set to dramatically increase. Currently, most device manufacturers use manual processes and document-based applications like Microsoft...
LifeSci Talks COA Series | Harnessing Implementation Science to Improve Health Outcomes: Methods and Approaches for the Future
Implementation science emerged as a response to the recognition that many effective health interventions and innovations were not being widely adopted or sustained in practice, even when evidence of their efficacy was strong. Join Meredith Smith, Senior Director of Implementation...
A Conversation with Dr. Elin Haf Davies of Aparito
The rare disease space presents numerous challenges for clinical research and patient data capture. These challenges are only heightened for younger patient populations, where outcome measures and dosages need to be considered appropriately. Join Dr. Elin Haf Davies, Founder &...