ABOUT INSEPTION GROUP

inSeption was built on the foundational principle that quality outsourcing solutions must consist of the RIGHT people. Our collective passion to bring treatments and an improved quality of life to patients, unifies us in our mission to change the outsourcing paradigm.

inSeption distinguishes people as the most impactful variable in the outsourcing equation. Our path-breaking model attracts biopharma companies who demand a partner that shares in their drive to conduct impeccable development and will provide quality and dependable clinical solutions. We offer full outsourcing, consulting services, and functional service provider (FSP) solutions for the following services:

FEATURED SERVICES

Provide end-to-end support and efficient solutions for every stage of the clinical trial lifecycle, including pre-study, startup, maintenance, reporting, and close-out services to support all clinical study needs. Our Clinical Operations subject matter experts are integrated into the client’s project team, thus ensuring a more streamlined approach to providing the required support and/or recommending ways to achieve new efficiencies.

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.

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

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.

Provide seamless collaboration on documents and submissions throughout a spectrum of services: medical writing, quality control review, document- and submission-level publishing, and health authority submission management.

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

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.

Ensure proper collection, verification, and delivery of Clinical Trial data through collaborative partnerships.

CONTACT INFORMATION

inSeption Group

870 W Main Street

Lansdale, PA 19446

UNITED STATES

Phone: (267) 498-5092

VIDEOS

  • Patient Over Process: The inSeption Group Difference

    Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.