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.

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:

CONTACT INFORMATION

inSeption Group

870 W Main Street

Lansdale, PA 19446

UNITED STATES

Phone: (267) 498-5092

VIDEOS

  • 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.

MYTHBUSTERS

  • Large CROs have a vast pool of resources and a subset of amazingly talented people. However, the decision to select such a CRO on the concept that they have access to the best talent, and the hope that those resources will be assigned to your study, is flawed.  

  • Most quantitative and qualitative studies seeking to understand what creates fear and anxiety in humans conclude with some version of the same 4 key criteria: Lack of Control, Large Consequence, Sudden Occurrence, and Unfamiliarity. In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair Contract Research Organization is quite daunting.

  • Chief medical officers looking for outsourcing services on a study are often fed lines from large CROs on how they can provide individuals with multitherapeutic backgrounds.

  • The theory of Corporate Memory is easy to understand and agree with – the better you record and understand recurring actions the better you will perform those actions. Read why Capitalizing on corporate memory might work at an individual level but is nothing more than a myth and an empty promise in the complex changing world of drug clinical studies.

  • Have you ever asked yourself why you take comfort with governance agreements? They're created to "protect" you when your CRO fails - and even then, what can you realistically do? You've already invested a large amount with them, and getting out of the contract is going to cost you. What's worse, if you work for a developing and emerging pharma biotech, a big box CRO can make you feel like they're throwing their weight around when all you're trying to do is hold them accountable to what they agreed to do in the first place.