Our Services

Clinical Program Development

Echelon Pharma Solutions offers you a source for experienced individuals to manage the planning, development and execution of drug development programs.

Deep Expertise in Protocol Development

Efficient, scientifically rigorous protocols developed by those with direct clinical trial experience provide the biopharmaceutical company with protocols that are executable and enable the data needed for regulatory submission.

Pediatric Programs

Our expertise involves understanding the special needs of pediatric programs. Our expertise is in helping develop a Pediatric Investigational Plan (PIP) aligned between the US FDA and the EU EMA, that achieves your regulatory requirements.

Experts in Compassionate Use

Patient groups provide critical insights to patient conditions throughout the course of a disease. They are highly motivated to help us learn about their disease so that we can incorporate their insights in advance of a clinical program.

Committees

Trial oversight committees provide a valuable resource to biopharmaceutical companies. These committees provide a sponsor with valuable guidance, oversee safety, and can review interim data when written into protocols with early stopping rules or adaptive designs.

Project Management

Together, in Echelon, we can help your company manage any clinical development challenge in small and large molecules, Phases 1 through 4.

Echelon Pharma Solutions will work with you in the strategic planning, development and execution of Clinical Programs

Trial Management

Effective management of a clinical trial requires experience. Our team of clinical trial specialists will work to your program specifications, timeline and budget. We ensure that your budget is used effectively and your data results in the quality required for registration. We will right-resource your trial to meet your needs.

Full Service Medical Writing

Regulatory Affairs

Echelon Clinical Programs and Regulatory Strategy expertise are the resources that you need to assist biopharmaceuitcal companies prepare for and manage the challenges of clinical trials and regulatory submissions.