Restoring Business Trust and Confidence
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The inSeption Group Difference

Everything we do is driven to challenge the status quo in the current outsourcing paradigm.

inSeption’s experts are defined by their insatiable passion to offer hope and make a difference for the patients we are serving during their fight for a better, longer life.

Known for our accessibility, responsiveness, and flexibility, our foundational model disrupts the current, inefficient outsourcing paradigm with higher-quality deliverables and far more consistent reliability.

The Right Change Starts with the Right People

Successful execution starts and ends with the right team. Our therapeutically aligned, highly experienced resources are driven by the science. This allows inSeption to arm decision-makers with timely information and the clinical insights they need. When we all share a singular purpose, success is all but guaranteed.

Our ability to attract the right people is our greatest asset.

Our Services

Clinical Operations and
Project Management

We provide efficient pre-study, initiation, interim, and close-out services to support all clinical study needs.

Site Management and
Clinical Monitoring

Our Regional Site Managers act as a “one-stop-shop” for all activities related to a clinical study site.

Medical Writing

We author clinical study protocols, clinical study reports, Investigator’s Brochures, briefing documents, safety narratives, and Modules 2 to 5 of the eCTD.

Quality Control

We fact-check and substantiate clinical study data and review punctuation, syntax, semantic errors, clarity of presentation, and consistency.

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.

Electronic Trial Master File

We utilize Veeva Systems, Inc. to maintain our clients’ eTMF with inspection-readiness practices incorporated into daily operations.

Regulatory Operations

We compile, format, and publish components of the eCTD to be submitted to health authorities worldwide.

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.

Contracts and Legal

We focus on handling all corporate legal matters, negotiating Sponsor MSA’s, SOW’s, vendor and site contracts/budgets.

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