Clinical Operations & Strategy

New proposals aim to create higher standards for trial regulation.

The need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.

Four industry executives share insights during the Media and Analyst Roundtable at Veeva's R&D and Quality Summit Connect.

Some actions to consider for your next trial or submission.

How one CRO in India quickly implemented processes and technology to mitigate risk

Elderly patients achieved up to 98% compliance at 18 months on Phase III study.

Sponsors can simplify diaries by taking a closer look at the three common sources of complexity.

Higher costs headline list of new challenges faced by CROs and sponsors.

What the next generation medication management in clinical trials should entail and insights on smart technologies and synergistic partnerships—backed by real-life implementation use cases.

Digitalization has revolutionized an industry once reliant on paper collection.

Capacity management and stability offer value for clients, their employees and FSP vendors.

Developing a higher level of critical thinking can create a comprehensive risk story and properly direct mitigations throughout your organization.

Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.

A focus on the position of law for e-signatures, their benefits, and the role of Clinical Research Malaysia in educating the industry on the practicality of e-signature.

How to assess common obstacles for opportunity and create more agile and adaptive clinical trials.

A summary of how organizations approached remote operating models and the experiences and effectiveness of clinical research professionals in their roles and responsibilities during the COVID-19 pandemic.

COVID-19 creates unique challenges for medical monitors.

How it has taken a global pandemic to reinforce the intrinsic benefits.

COVID-19 reshaping the roles of CRAs overseas as industry shifts to remote monitoring.

There's no one-size-fits-all approach during the COVID-19 pandemic

Behind-the-scenes look at vaccine development.

Compression between phases to accelerate cycle time.

Assessing the opportunities, considerations and implications of decentralized trials—and why they’re here to stay

The pandemic spurred an urgency to innovate that improved clinical development in ways that should benefit the industry beyond COVID-19.

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.