In this ISSUE

Finally, Standardized KPIs are Front and Center

Modeling and Simulation in Clinical Trials: Real Potential or Hype?

The US and the Location of Clinical Sites

The CRO Oversight Benchmark Report outlines Challenges and Best Practices in Continuous CRO Oversight. It details responses from global Sponsors regarding goals, process issues, and objectives in compliance, risk, and collaboration. Gain insights from program, study and vendor oversight teams on how they are approaching their initiatives.

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Regulatory Authorities, FDA

FDA Examines Eligibility Criteria in Clinical Trial Design and Product Development

Recent legislation authorizes further assessment of FDA eligibility policies and of NIH research standards.
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Functional Service Models Reimagined: Integrating services and innovation for accelerated clinical development
Wednesday, June 6, 2018 at 11am EDT

Budgeting

Risk Based Budgeting

Adoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.
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Considerations when Addressing the Challenges of Time, Cost, and Data Standardization in Clinical Trials
Thursday, May 10, 2018 at 11am EDT/ 8am PDT/ 4pm BST/ 5pm CEST

News

Millennials and their Impact on Clinical Research

The importance of examining this generation’s influence on the clinical trial value chain.
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Medicine Use and Spending in the U.S. A Review of 2017 and Outlook to 2022
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The Future of ECOA
Tuesday, June 12, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Calendar

/ Managed Access Programmes and Accelerated Pathways 5/16-5/17 /

/ BIO International Convention 6/4-6/7 /

/ 7th Annual Publication and Clinical Trial Transparency 6/20-6/21 /

American Pharma Outsourcing Summit 10/2-10/3 /

Protein Biotherapeutic BioAnalysis, by Immunoaffinity LC-MS: Latest Trends and Recommendations
Live Webcast: Tuesday, May 15 at 11:00am EDT

Ask the editor

Lisa Henderson
Editor in Chief
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Todd Baker
Group Publisher
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Operationalizing Gene Therapy Trials
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Lab Data

Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment

Biomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.
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Six Strategies for More Accurate Clinical Trial Forecasting & Budgeting
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Patient Centricity

#OnePersonCloser for HCP Awareness

Lisa Henderson writes on patient participation and recruitment in clinical trials.
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Where Expertise Meets Nuance: Conducting PTSD Clinical Trials
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