Scientific Advisory Board Announcement
FOR IMMEDIATE RELEASE inSeption Group Forms Scientific Advisory Board, Welcoming Industry Trailblazers […]
Is There Really Less Risk In Selecting a Large CRO?
The article discusses the perceived risks and benefits of choosing a large […]
The Great Rehire: Finding Your Fit In Today’s Clinical Research Industry
The article explores the evolving clinical research industry, particularly how the hiring […]
Outsourcing Vendor Red Flag #1: Copy-and-Paste Bids & Cookie Cutter Contracts
Adept CRO communication doesn’t just indicate the vendor’s ability to deliver a […]
Outsourcing Vendor Red Flag #2: Layers of Oversight And Process Are Impeding My Program
Depth of management typically is less about ensuring your trial progresses smoothly […]
Outsourcing Vendor Red Flag #3: A Bid Is Inaccurate Or Suspiciously Low
Adept CRO communication doesn’t just indicate the vendor’s ability to deliver a […]
Strategies for a More Secure Outsourcing Bottom Line
The article discusses strategies for securing a more stable and cost-effective outsourcing […]
Leveraging Clinical Trial Data In Real Time To Effect Change And Mitigate Risk
The article discusses the untapped potential of real-time clinical trial data analytics […]
Why Collaborative Protocol Design Is Vital To Autologous Cell Therapy Clinical Trials
Collaborative protocol design is essential in the development of autologous cell therapy […]
Remote Clinical Trial Monitoring: CRA Success In An Era Of Autonomy
The COVID-19 pandemic has accelerated the adoption of remote work in clinical […]
Why Site And Partner Communications Are Critical To Autologous Cell Therapy Clinical Trials
Effective communication between clinical trial sites and partners is crucial for the […]
Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
Efficient time management, streamlined logistics, and standardized manufacturing processes are critical for […]
Clinical Research Considerations For Rare Disease Patients: Part 1 — Reinvigorate Patient Centricity
The article emphasizes the need for a shift towards patient-centric approaches in […]
Clinical Research Considerations For Rare Disease Patients: Part 2 — The Impact Of Physician And Site Support
Physician and site support are critical for the success of rare disease […]
The Write Side of AI: Helping Hands, Not Replacement Plans
The article explores the role of AI in medical writing, emphasizing that […]
Philadelphia Business Journal’s 2025 Best Places to Work
FOR IMMEDIATE RELEASE inSeption Group Named One of Philadelphia Business Journal’s 2025 […]
inSeption Group Partners with Pennsylvania Biotechnology Center
FOR IMMEDIATE RELEASE inSeption Group Partners with Pennsylvania Biotechnology Center to Support […]
Recovering A Clinical Trial That Has Been Derailed
When your asset is on the line, your partner of choice matters […]
Dawn Niccum Named CPR Chair-Elect, 2024
inSeption Group is thrilled to announce that Dawn Niccum has been designated […]
Entrepreneur of the Year
inSeption Group Co-Founders and Managing Partners Joe Arcangelo and Brian Sulpizio Named […]
Philadelphia Business Journal’s Fast 50 Growing Companies 2024
[Lansdale, PA] – [August 13th, 2024] – inSeption Group, a leading clinical outsourcing […]
Lori Buckenmyer
Meet our Executive Director, Clinical Operations and Project Management
Dawn Niccum
Meet our Executive Vice President, Quality Assurance
High-Velocity Development: Gene Therapy Vs. Small Molecule
Gene therapy development operates at a high velocity compared to small molecule […]
Jenny Minigh
Meet our Executive Vice President, Medical Writing
Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
Discover why the science that brought you to this point can only […]
CRAs Must Evolve Alongside Oncology Therapeutics
Clinical Research Associates (CRAs) must adapt to the evolving demands of oncology […]
Crissy Reynolds
Meet our Senior Director, Regulatory Operations
Raul P. Lima
Meet our Executive Vice President, Clinical Operations
Karin Rezzonico
Meet our Senior Director, Quality Assurance & Compliance
Our message to CMOs
For over 12 years, we’ve stood alongside the Chief Medical Officer Summit […]
FDA Update on ICH E6, E8, QbD and RBM in Clinical Trials
Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) approaches in clinical […]
Revolutionizing Clinical Trials: The Power And Potential Of Risk-Based Monitoring
The article explores the benefits and misconceptions of risk-based monitoring (RBM) in […]
How Sponsors and Patients Benefit From a Site-Centric Partnership
Site-centric partnerships between sponsors and clinical trial sites can significantly enhance patient […]
Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?
Evaluating the suitability of multitherapeutic contract research organizations (CROs) for clinical trials […]
Successful Regulatory Submission Via the Trifecta of Awesomeness
The article discusses the key elements that lead to a successful regulatory […]
Slow the Burn: How to Make Risk-Resilient Vendor Choices
Many pharmaceutical industry experts share similar principles for reducing financial risk when […]
What’s Wrong With My Trial? Uncovering The Root Cause Of Clinical Trial Troubles
Progress can be negatively impacted by clinical trials that hit obstacles. These […]
How to Establish Effective, Scalable Drug Safety Ops Across Multiple Vendors
Effectively managing drug safety operations across multiple vendors is crucial to ensure […]
Second Time’s The Charm — Navigating NDA Submission, Plus A Resubmission Rescue Mission
The article outlines the challenges faced by a biopharmaceutical company during its […]
Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
Discover why the science that brought you to this point can only […]
Why the Regional Site Manager Is the Swiss Army Knife of Clinical Trial Monitoring
The Regional Site Manager (RSM) monitoring model enhances clinical trial oversight by […]
Top 5 Considerations For CAR-T Trials During A Macroeconomic Downturn
Navigating CAR-T cell therapy trials during economic downturns requires strategic approaches to […]
Modernize TMF Culture to Better Support Modern Clinical Trials
The article focuses on the need to modernize Trial Master File (TMF) […]
Identifying The Best People To Run A Clinical Study (And How To Hire Them)
The article emphasizes the importance of identifying and hiring top talent to […]
Great Size ≠ Great Value: How Smaller Outsourcing Partners Benefit Small And Emerging Biotechs
The article highlights the advantages of partnering with smaller outsourcing firms for […]
The Fallacy of the Corporate Memory Concept
The article challenges the concept of “corporate memory” within large CROs, arguing […]
Do You Take Comfort In Governance Agreements
The article delves into the limitations of governance agreements with large CROs, […]
Keys to Successful Risk Management in Clinical Trials
The article emphasizes the critical role of comprehensive risk management in clinical […]
Natural History Studies in Gene Therapy Trials: Benefits, Timing and Execution
Natural history studies (NHS) in gene therapy trials are essential for understanding […]
Diverse Mentorship Models Create Multiple Paths To Employee Success
Mentorship models create multiple paths to employee success by fostering deeper, more […]
Quality Control in Medical Writing: What It Means and Why It Matters
The article discusses the critical role of quality control (QC) in medical […]
Evolving Trial Master Files Require Experienced TMF Resourcing
This blog post highlights the challenges inexperienced individuals face in maintaining a […]
Shifting the Approach: 4 Strategies for ICH E6(R3) Implementation
Implementing the ICH E6(R3) guidelines requires organizations to adopt a proportionate approach […]
Gap Analysis and Collaboration Lead to Success
Conducting a comprehensive gap analysis and fostering collaboration within your organization’s quality […]
The Critical Role of the Medical Monitor In A Clinical Study
The Medical Monitor plays a crucial role in clinical trials, primarily ensuring […]
How Sponsors and Patients Benefit from a Site-Centric Partnership
Creating a site-centric partnership between a pharmaceutical/biopharmaceutical sponsor and a clinical trial […]
Site-Relationship Strategy: Ensuring Quality Data and Study Performance
The article explores the importance of strong site-relationship strategies in clinical trials […]
CMO Testimonials
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The Cooperativity Program
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Quality Assurance: Embedded In Excellence
https://vimeo.com/926303759?loop=0
What Is Quality?
https://vimeo.com/805669368?loop=0
Beyond Compliance: TMF Done Right
https://vimeo.com/796669165?loop=0