Your clinical trial deserves a safe landing.

Clinical trials are complex.
We make them fly.

At Blue Parachute, our experienced team of pharmaceutical experts help sponsors identify risks early, navigate clinical trial complexity, and maintain momentum through experienced oversight and hands-on support.

Clinical Operations

We support sponsors’ internal clinical operations teams with a focus on timelines, risk identification, issue resolution, and inspection readiness in phase 1-3 programs and study oversight. Additionally, we support CRO selection, scope and budget evaluation, and performance monitoring.

Trial Master File Management

To ensure TMFs are inspection-ready and appropriately managed by your CRO, we provide targeted sponsor-side support with low-cost, high-quality TMF health checks. These assessments for completeness, quality, and risk are based on TMF setup, structure alignment, and filing conventions.

Site Monitoring & CRA Support

We provide flexible monitoring coverage to continue assisting you with protocol adherence and operational troubleshooting. To supplement existing oversight models, we complete targeted monitoring and CRA support.

Data Quality & Database Support

Focusing on sponsor-side support to help identify and address data risks early, we proactively identify risks to ensure data accuracy, compliance, and operational feasibility in your database designs. These designs lead to more efficient data listings review, cross system reconciliation, and issue trending.

Medical Monitoring Support

By identifying trends in clinical and safety data reviews, we provide experienced support for routine medical monitoring and safety oversight. To ensure further support, we refer to the latest information on medical coding and safety process support from MedDRA and WHO-Drug.

Hand-Selected Expertise

Blue Parachute knows every project is different, which is why we choose our teams based on our client needs. If our team uncovers additional areas of concern, we'll leverage our extensive range of expertise to guide your project to a safe landing.

Meet our leadership →

Why Our Clients Love Us...

"As a small, fast-moving biotech, we need partners who can run at our pace. The Blue Parachute team does exactly that. They step in as part of the Sponsor’s team, not as outside consultants, and bring both strategic insight and hands-on execution. Their ability to keep up with the speed and complexity of early clinical development has been invaluable."

Clinical Operations project lead, small biotech

"What you are doing makes such a difference to so many with your expertise, no-nonsense approach, your eye always on quality, and your patience and perseverance in navigating chaotic and frustrating situations. I am honored and grateful to work with all of you."

Clinical Operations project lead, small biotech

"You are delightful and fun to work with, again, despite some difficult terrain in every-changing landscapes."

Chief Medical Officer, small biotech

"Blue Parachute never felt like a traditional consulting firm. Their team integrates seamlessly with our organization and operates as true partners. They bring deep clinical and medical expertise, build strong relationships across functions, and consistently go above and beyond to help us move programs forward."

Chief Medical Officer, small biotech

"The SOP work you have done is tremendous. This is the third SOP optimization project in our company, and no one has done this amount of work in this amount of time. Not even close. Thank you very much!"

Sr. Director Regulatory Affairs

"At the last DSMB meeting, the members all agreed: this was the most efficient display of data they’ve ever seen. All sponsors should do their outputs like this."

Medical Director, small biotech

Meet our leadership

Amy Longcore, MS

CEO & Founder

Lorelei Anderson, MS

VP of Clinical Operations

Robin Schmidt, MS

VP of Clinical Operations

Over 300 years of industry experience

Collectively, our core team of clinical professionals — including MDs, PhDs, PharmDs, and more — has over 300 years of industry experience which we use to tackle complex issues and deliver high-quality results.

We are always looking for detail-oriented, experienced individuals to join our team. Send us your CV today!

Apply Now

Frequently asked questions

Blue Parachute offers concierge clinical trial support to small- and mid-sized biopharma teams. From early development through late phase, we drop in fast, stabilize your study, and keep timelines, quality, and budgets on course. We bring deep experience and technical excellence, grounded in a people-first mindset. Every project we take on is guided by a commitment to listening first, understanding fully, and delivering a safe, successful landing for your clinical trial.

Every engagement starts with understanding your unique needs. We take the time to listen and learn about your study, your team, and your priorities before developing an onboarding plan tailored to your organization. Whether you need support for a specific project or ongoing clinical operations leadership, we work alongside your team to integrate quickly, establish clear communication, and begin delivering value from day one.