SOLUTIONS

Clinical Trial Consulting

Confidently make informed decisions and advance your product along the development pathway with support from our regulatory, clinical, medical, and biometrics consultants.

Work with a clinical trial consultant:

With deep clinical trial expertise and a consultative approach, the PharPoint team can provide strategic support to help guide pharmaceutical, biotechnology, and medical device companies as they develop their drug development programs from pre-IND planning through regulatory approval.

Program Strategy

Work with our experts for IND submission support, strategic development planning and maintenance, and program review.

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Regulatory Consulting

Partner with regulatory experts to lay out a pathway to approval, including strategy development and review, expedited pathway exploration, and regulatory meeting support and representation.

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ICH E6(R3) Compliance

Is your team prepared for ICH E6(R3)? Work with a consultant to assess your current status and build practical, organization-wide changes that support a shift toward proactive, risk-based quality.

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QA Consulting

Our quality consultants have deep expertise within GxP and can help sponsors assess current workflows, identify risk areas, and guide teams through practical improvements.

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Trial planning & conduct

Get Phase 1-4 trial support, including protocol design, risk mitigation, Key Opinion Leader (KOL) network development, or investigative site feasibility.

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Everyone talks about “quality culture.” But can you be certain your team and vendors have it? Discover the practical indicators that separate the buzz from the real thing.

→ Read: Evaluating Quality Culture in Clinical Research: Beyond the Buzzword

Related Resources

Explore resources and perspectives from our team

Evaluating Quality Culture in Clinical Research

Evaluating Quality Culture in Clinical Research: Beyond the Buzzword While it’s one thing to discuss a culture of quality in clinical research, it’s much more complicated to make it a reality – embedded into the way teams think, act, and make decisions across an entire organization. This echoes timeless guidance from

Clinical Trial Design: Ensuring Statistical Validity and Identifying Consulting Biostatisticians

Why engage a biostatistician early in the study design process, and how do you identify the right consultant for your study?

Exploring Benefits, Eligibility, and Key Considerations for Sponsors Pursuing Orphan Drug Designation

Pursuing Orphan Drug Designation? Navigating the nuances of eligibility and the application process can be complex.

How to Create a Comprehensive Clinical Development Strategy

A strategic clinical development plan (CDP) can help Sponsors optimize their new drug programs. What should you include in your CDP?

Medical Device Clinical Trials: Classification & Challenges

(Originally submitted to surfaces.org's SurFACTS in Biomaterials Volume 26 Issue 3.) An overview of medical device clinical trials, discussing device classification and challenge unique from drug/biologics trials.

Let’s talk

Reach out to schedule an introduction and learn more about how our clinical trial consultants can support your team.