The Right People

Our people are the key variable in the outsourcing equation.  We are unified by a passion to improve the quality of life of the patients our clients serve.

We hand select an elite team for each and every project to ensure a seamless integration for our clients.  We provide valuable continuity that extends beyond a single program.  Our people share attributes of curiosity, ingenuity, tenacity, and integrity.

As architects of a shared vision, inSeption capitalizes on our clients’ talents by blending in complementary strengths to maximize operational and cost efficiencies.

We have extensive experience in all phases of clinical development and across a broad range of therapeutic areas.

Our professionals comprise the top 20% of the market.

Medical Writing

We author documents that support research and development and marketing needs.  Our expertise include clinical study protocols, clinical study reports, Investigator’s brochures, briefing documents, safety narratives, and Modules 2 to 5 of the CTD. Learn More…

Quality Control

We fact-check and substantiate clinical study data and review punctuation, syntax, semantic errors, clarity of presentation, and consistency. We collaborate with the client to customize the QC process and checklist.Learn More…

Regulatory Operations

We help our clients plan, manage, and execute upon any clinical document submission and publishing need. We compile, format, and publish components of the electronic CTD to be submitted to health authorities worldwide.Learn More…

Electronic Trial Master File

We utilize Vault eTMF (Veeva Systems, Inc.) to provide unique and scalable solutions to maintain our clients’ eTMF with inspection-readiness practices incorporated into daily operations.Learn More…

Clinical
Operations

We provide efficient pre-study, initiation, interim, and close-out services to support all clinical study needs.  Our teams comprise fully dedicated, experienced clinical professionals who provide quality work and are driven by service.Learn More…

Site Management and
Clinical Monitoring

Our Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites. Our RSMs can act as a “one-stop shop” for all activities related to a clinical study site. Learn More…

Quality
Assurance

We establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.Learn More…

Biostatistical Services and Programming

We partner with experts who share in our commitment to quality and have a proven ability to produce high quality biostatistical and clinical programming deliverables on time and within budget.Learn More…