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Clinical Research Resources

Check out our whitepapers, webinars, tools, articles and more! Click on the links below to learn more about each resource and to get access to the resource.

Clinical Trials Resources

7 Tips to Use Social and Digital Media to Recruit and Engage with Clinical  Trial Patients

Download: Taking the Risk Out of Risk-Based Monitoring

Webinar: Selecting Inclusion/Exclusion Criteria for Your Next Trial

Download: 5 Tips for Conducting Feasibility for a New Clinical Trial

Download: Craftsmanship in Clinical Study Design

Download: 4 Types of Efficacy Outcomes to Consider in Phase 2

Download: Working in Vulnerable Patient Populations

Webinar: ePRO and Smart Devices

Download: Clinical Endpoints Article

TMF Reference Model Webinar

Download: Addressing Diversity in Clinical Trials

Download: 5 Things You Should Know about Phase 1 Clinical Trials

Download: 4 Types of Dose Finding Studies

When Placebo Response Isn't Placebo Response: The Perils of Human Raters

Regulatory Considerations for Using Social Media in Clinical Trial Patient  Recruitment

Regulatory Submissions Resources

Download: Marketing Application Planning Tool

Webinar: Tips for a Smooth NDA Submission

Webinar: Get Your Development Program Started on the Right Foot

Webinar: Expedited Development & Approval Regulatory Pathways

Download: The US Biosimilars Approval Pathway-- Policy Procedes Science

Protocol Design & Development: What You Need to Know to Ensure a Successful  Study

Download: Accelerated Approvals White Paper

Bridging the Gap Between Technical/Data Standards & Regulatory/Medical Writing  in NDA Submissions

Webinar: Worried About Your Next FDA Meeting?

Download: Special Protocol Assessment White Paper

View Key Tips to Orphan Product Development Presentation

Post-Lock Data Flow: From CRF to FDA

Webinar: Understanding the FDA Guidance on Data Standards

Webinar: Keys to Success for Your ISS/ISE

Clinical Outsourcing Resources

Download: RFP Specifications Tool

Webinar: Optimizing Sponsor/CRO Relationships

5 Tips for Creating an RFP

Download: 5 Challenges in Site CRO Relationships

Download: 5 Red Flags Your CRO is Putting Your Clinical Trial at Risk

Download: 4 Tips for Selecting a Functional Service Provider (FSP)

Download: Planning the RFP Process

Download: Which Type of Contract is Right for Your Next Clinical Trial?