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The article discusses the key elements that lead to a successful regulatory submission: strategic planning, team engagement, and leveraging team experience. It emphasizes that well-structured planning and clear team communication are crucial to avoiding delays and ensuring high-quality submissions. A well-prepared team with the right experience and organizational practices is essential to overcoming obstacles during the submission process.
Clinical trials are critical for advancing medical treatments, but they frequently encounter delays and recruitment challenges. Optimizing the initial stages of protocol design and outsourcing strategies is essential for streamlining these trials. Raul P. Lima, MA, MBA, EVP of Strategic Clinical Operations at inSeption Group, was recently a guest on PharmaTalkRadio, where he shared his expertise on these crucial aspects.
Raul sheds light on common misunderstandings among Chief Medical Officers (CMOs) about the vital role of clinical operations offers strategies for navigating the complexities of clinical trial execution.
Key Takeaways from the Podcast:
Listen to the full podcast here to learn more about improving efficiency and success rates in clinical trials through better clinical operations.
Clinical trials are becoming increasingly complex, with evolving regulations, longer timelines, and heightened risks that can threaten study success. The key to navigating these challenges? A proactive, well-documented risk management strategy that adapts over time.
This article dives into the core principles of clinical trial risk management—how to identify critical risks, ensure stakeholder ownership, and apply best practices that safeguard data integrity and compliance. Discover why early planning, dynamic risk registers, and the right tools can make all the difference in keeping trials on track.
👉 Read the full article here:
FOR IMMEDIATE RELEASE
inSeption Group Partners with Pennsylvania Biotechnology Center to Support Early-Stage Biotech Companies
Audubon, PA, January 7, 2025 — inSeption Group is proud to announce its strategic partnership with the Pennsylvania Biotechnology Center (PABC) as the exclusive outsourcing partner for the PABC and B+Labs community. Through this collaboration, inSeption Group will provide crucial strategic guidance and support to early-stage biotech companies in the PABC ecosystem, helping them navigate the complexities of early trial planning and development.
This partnership aligns with both organizations’ missions to accelerate life sciences innovations and enhance support for emerging biotech companies. As the exclusive partner, inSeption Group will deliver its industry-leading expertise in clinical outsourcing, offering tailored services to streamline early development processes and expedite the path from discovery to clinical trials.
“Our collaboration with the Pennsylvania Biotechnology Center represents a shared commitment to supporting early-stage companies at the most critical points in their development journey,” said Joe Arcangelo, Co-Founder and Managing Director of inSeption Group. “By providing customized guidance and strategic planning, we aim to empower these innovators to achieve their clinical milestones more efficiently and successfully.”
Supporting the Growth of Philadelphia’s Life Sciences Ecosystem
The PABC has established itself as a leader in nurturing the next generation of biotech innovators. By leveraging inSeption Group’s extensive experience in trial planning and clinical research, the partnership aims to equip member companies with the resources and expertise necessary for successful trial execution and regulatory compliance.
“We are thrilled to welcome inSeption Group as a partner,” said Lou Kassa, Chief Executive Officer, Pennsylvania Biotechnology Center. “Their hands-on experience and commitment to client success align perfectly with our mission to support our member companies. Together, we can provide the strategic and operational support necessary for these companies to thrive.”
About inSeption Group
Founded in 2011, inSeption Group was created with the vision to restore business trust and confidence in the clinical outsourcing industry. inSeption Group delivers an unparalleled level of service to biotech and pharma companies conducting clinical programs and submissions in highly complex therapeutic areas such as oncology, neurodegenerative disorders, and rare diseases. inSeption expertise spans the clinical research lifecycle including early trial planning, project management, regulatory submissions support, and more. Over time, it has become a home for a subset of professionals who hold themselves to high standards of quality and personal accountability. In the changing landscape of clinical research, we’re creating a new kind of future. One where integrity outweighs self-interest, where transparency cultivates trust, and where people deliver on their promises. For more information, please visit our website at inseptiongroup.com and follow us on LinkedIn.
About the Pennsylvania Biotechnology Center (PABC)
The PABC uses a highly successful services-based approach to nurture and guide its member companies to success, advance biotechnology, and maximize synergies among nonprofit scientists and their commercial colleagues. The PABC has nearly 100 member companies and organizations, mostly small to mid-size science, research, and pharmaceutical companies. Nearly 50 of these companies operate on the Doylestown campus, which is home to the Hepatitis B Foundation and the Blumberg Institute. The PABC also manages B+Labs at Cira Centre, a new incubator in Philadelphia, in partnership with Brandywine Realty Trust. PABC companies have produced numerous FDA-approved drugs and medical devices, with a recent study showing that the PABC’s economic impact exceeded $7.3 billion and created more than 1,100 new jobs during 2016-2021.
For more information, please visit our website and follow us on LinkedIn, Instagram, Twitter (@BiotechnologyPa), and Facebook.
Media Contact:
Kristin Morris
Senior Director, Corporate Communications
kmorris@inseptiongroup.com
267-397-8980
870 W Main Street | Landsdale, PA
Join us to learn about our range of strategic and planning services, including clinical development plans, clinical trial protocols, regulatory submission strategy, and more.
inSeption Group Named One of Philadelphia’s Fastest-Growing Companies in 2024 by Philadelphia Business Journal
[Lansdale, PA] – [August 13th, 2024] – inSeption Group, a leading clinical outsourcing company, is proud to announce that it has been named an honoree in the Philadelphia Business Journal’s Fast 50 Growing companies of the greater Philadelphia area.
The Fast 50 award, formerly known as the Soaring 76 award, celebrates companies that have achieved a level of sustained, substantial growth over the past 2 years.
inSeption Group’s distinctive approach to providing clinical research services to biotech and pharma clients has been pivotal in driving sustained growth. By prioritizing quality, adaptability, and employee continuity and aligning experience and passion with each client’s unique needs, inSeption is reshaping the culture of clinical outsourcing.
“It’s no small feat to build a business. Sustaining a high level of growth throughout the years, even through a pandemic, is all the more impressive, and we’re honored to be included on this list with other businesses who have faced and risen above similar challenges. For us, this is yet another signpost letting us know we’re headed in the right direction, one that is pointing to the power of hiring the right people, creating an environment in which they choose to stay, and delivering on our promises.”
For more information about inSeption Group and its award-winning workplace culture, please visit inseptiongroup.com or contact Joe Arcangelo at 267-498-5092 or Brian Sulpizio at 215-855-7403.
About inSeption Group
Founded in 2011, inSeption Group was created with the vision to restore business trust and confidence in the clinical outsourcing industry. Over time, it has become a home for a subset of professionals who hold themselves to high standards of quality and personal accountability. inSeption Group delivers an unparalleled level of service to biotech and pharma companies conducting clinical programs and submissions in oncology, neurodegenerative disorders, and rare disease. In the changing landscape of clinical research, we’re creating a new kind of future. One where integrity outweighs self-interest, where transparency cultivates trust, and where people deliver on their promises.
Media Contact:
Kristin Morris
Senior Director, Corporate Communications
kmorris@inseptiongroup.com
267-397-8980
870 W Main Street | Landsdale, PA
inSeption Group Co-Founders and Managing Partners Joe Arcangelo and Brian Sulpizio Named as EY Entrepreneurs of the Year Greater Philadelphia Award Winners
On June 6, 2024, Ernst & Young LLP announced that Joe Arcangelo and Brian Sulpizio, Co-founders and Managing Partners of inSeption Group, were named Entrepreneurs of the Year 2024 in the Greater Philadelphia region. Members of the Greater Philadelphia business community gathered for this annual awards program to honor the 32 finalists, who had been selected from a pool of more than 50 entrants.
Over a period of several months, the candidates held several interviews with a panel of independent judges made up of entrepreneurs and other notable business leaders and were evaluated based on their demonstration of building long-term value through entrepreneurial spirit, purpose, growth, and impact.
Other finalists included leaders in the tech, construction, and healthcare industries. Winners shared stories of perseverance, testaments to their teams, and lessons they learned from their families, mentors, and own challenges. A resounding theme emerged throughout the evening: entrepreneurship can be a hard and uncertain road—but it can change the world.
“Let’s be honest. This recognition is really the recognition of our extraordinary employees. It is a tribute to their integrity, dedication and unwavering commitment to excellence.
I am honored to accept this award on their behalf, yet another signpost along the journey pointing to the power of engaging the right people.” – Brian Sulpizio
“I’m deeply honored to receive the 2024 EY Entrepreneur of the Year Award and grateful for the recognition of our team’s hard work. Thank you to everyone at inSeption. Your effort and determination have been crucial to our success. This award is a testament to our collective efforts and a motivation to continue our pursuit of excellence. I’m excited to see what we will accomplish next, inspired by our dedication to the patients we serve.” – Joseph Arcangelo
As Greater Philadelphia winners, Joe and Brian are now eligible for the National Entrepreneur of the Year Award, which will be announced in Palm Springs, CA in November. There they will join other regional winners for the Strategic Growth Forum™, a curated networking and learning experience.
Thank you to Ernst & Young, LLP, and those sponsors and judges who contributed to a wonderful evening celebrating entrepreneurship in Greater Philadelphia.
About the EY Entrepreneur of the Year Awards
Founded in 1986, the EY Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally.
About inSeption Group
Founded in 2011, inSeption Group was created with the vision to restore business trust and confidence in the clinical outsourcing industry. Over time, it has become a home for a subset of professionals who hold themselves to high standards of quality and personal accountability. inSeption Group delivers an unparalleled level of service to biotech and pharma companies conducting clinical programs and submissions in oncology, neurodegenerative disorders, and rare disease. In the changing landscape of clinical research, we’re creating a new kind of future. One where integrity outweighs self-interest, where transparency cultivates trust, and where people deliver on their promises.
Media Contact:
Kristin Morris
Senior Director, Corporate Communications
kmorris@inseptiongroup.com
267-397-8980
870 W Main Street | Landsdale, PA