inSeption Group | Full-Service Outsourcing

Restoring

Quality

“I was drawn to inSeption by the people — everyone is so passionate about what they do. Quality Control is one of the last stops before a document is submitted, and timelines change frequently. As a smaller company, we’re empowered to be ﬂexible, agile, and responsive to meet our clients’ needs.
Whether it’s a small document or a large submission, knowing we play a role in delivering lifesaving medicines to patients is what gets me ﬁred up to work every day.”

– KATIE ROBBINS, ASSOCIATE DIRECTOR
QUALITY CONTROL

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Restoring

Teamwork

"After twenty plus years at a CRO, I came to inSeption in 2017 and I have to say it was the best career decision I ever made. Each day has a new challenge that allows me to work with different departments, clients, and numerous job duties every day. I am consistently learning the functions of all the services inSeption provides as well as working directly with clients on budgets and proposals. The inSeption Managing Partners encourage personal growth, brainstorming, and process improvements, as well as daily and direct interaction with everyone which is rare in most companies."

– Stephen Hamson
Director, Business Operations

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Restoring

Hope

"Successful execution starts and ends with our team and when we all share one goal, hope can be endless."

– Christine Reynolds
Regulatory Operations Director

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Restoring

Confidence

“I’m honored to work for a company that stands for integrity and quality. But what I love even more is ISG’s dedication to providing real solutions for our clients’ needs. Whatever the request, we can help. Our ambition is to help others succeed.”

– JENNY MINIGH,
EXECUTIVE DIRECTOR, MEDICAL WRITING

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Restoring

Integrity

“I can honestly say I work at the best company in the world. There is something special about gathering a group of likeminded, passionate, hardworking individuals — amazing things happen. We are creating something bigger than ourselves. I am proud of coming to work each day and doing what I do. We contribute to value and change, which is a feeling that cannot be duplicated.”

– JOSEPH CALPAS, RESOURCING MANAGER, REGULATORY DOCUMENTATION SERVICES

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Restoring

Transparency

“My passion is helping patients with rare diseases. Working at inSeption Group has given me the opportunity to be the lead writer on gene therapy documents across the entire clinical development program, from the initial IND to BLA and MAA submissions. Our team of experienced gene therapy writers works with clients to make a diﬀerence in patients’ lives.”

– ROBIN JOHNSON, GENE THERAPY LEAD

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Restoring

Trust

“Quality Risk Management is a critical activity as part of the clinical trial process, not just a check box activity. We have the expertise to identify and mitigate risks that matter with our Sponsor team throughout the entire study lifecycle. Our team remembers that the ultimate goal of the clinical trial is bringing new and better therapeutics to patients and hopefully provide a better, longer life.”

– DAWN NICCUM, VICE PRESIDENT, QUALITY ASSURANCE & COMPLIANCE

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Restoring

Pride

“I have always been passionate about helping others. Working in Regulatory Operations allows me to follow my passion by helping life sciences companies with their submissions goals and bringing new life-saving medicines to the market. In this ﬁeld, I work alongside some great individuals every day, all dedicated to bringing therapies and an improved quality of life to patients around the world.”

– KULWINDER KAUR, DIRECTOR,
REGULATORY OPERATIONS

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Restoring

Passion

"One of the things that attracted me to InSeption Group is that it does not feel like work. It just feels like I am doing something I love to do every day. It helps that I collaborate with great people who all participate as a team to achieve company goals. Helping our clients get products to the market so that people can get what they need is very fulfilling."

– Keirre Threats
Manager, Regulatory Operations

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Restoring

Reliability

“Successful execution starts and ends with the right team. Our Clinical Operations team is driven by a passion to focus on patients and to provide quality data.
That is very diﬀerent than just 'checking the boxes' which has unfortunately become an industry norm. We establish partnerships with our sponsors and clinical sites built upon trust, reliability, and integrity. When we all share one common purpose, hope can ﬂourish.”

– LORI BUCKENMYER, HEAD OF CLINICAL OPERATIONS AND PROJECT MANAGEMENT

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Restoring

Collaboration

"Being part of inSeption's Quality Assurance team allows me to do what I do best. By making personal connections with the client, I can engage in collaborative dialogue and ask poignant questions to streamline risk and provide the support that matters. I am honored to be able to follow my passion for helping others and be part of bringing new therapies to patients who need them most."

– Karin Rezzonico
Sr. Director, QA Auditing

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A Full-Service Outsourcing Solution

Focused within Oncology, Hematology, Neurodegenerative Disorders, and Rare/Orphan Disease with a specialization in Cell and Gene Therapy.

We provide an outsourcing solution designed to disrupt the current paradigm, resurrecting a common-sense approach to rebuild business trust and confidence.

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97%

client satisfaction

<6%

employee turnover

94%

repeat business

We stand out from our competitors not by what we say, but by what we do every day.

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.

Over time, there’s been a shift from patient-focused, service-centric obligations to a primary emphasis on fiscal performance. Our founders, like you, have witnessed this progressive degradation of the reliability of today’s outsourcing options. This vulnerability can be costly and frustrating and is the driving force behind the inSeption difference.

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

"I can’t even begin to express how comfortable we feel in your trusted hands. I was impressed with your core values. They can serve as a north star for both of our organizations. We look forward to a fruitful partnership as we bring these new drugs to the patients who desperately need them." Head of Clinical Development Cell & Gene Therapy Organization targeting previously untreatable disease

"Just a quick note of thanks for your efforts with our budgeting process. It was a lot of work, but you were always available, pleasant, and highly competent. You’re a pleasure to work with." Chief Medical Officer Gene Therapy organization with an emphasis on rare blood disorders

"Speaking with you all, sharing our common goals, was truly the highlight of my month! I am looking forward to working with you both and meeting other like minds." Regional Clinical Research Associate Hematology & Oncology specialist

"I am very impressed by inSeption Group and have been chatting you up to my colleagues." President & Chief Scientific Officer Gene Therapy organization concentrating on rare genetic diseases

"I must say you went above and beyond here. That goes a very long way in my mind and as I move forward, I will keep inSeption Group in my toolbox of resources." Senior Director, Clinical Operations Organization treating Rare Pulmonary diseases

"You guys are really the best." Chief Executive Officer Cell Therapy organization with an emphaisis on Solid Tumor indications