State of the Business

BY JOSEPH ARCANGELO


“In business, the definition of insanity is doing what you have always done but expecting a different result.”

— AUTHOR UNKNOWN

Nine years ago, we began a journey based upon a simple idea: that those responsible for developing life-saving treatments had begun to accept mediocrity from their outsourcing vendors. Their stories were so similar:

“I might as well have done it myself.”

“You know it will cost about 20% more than you are quoted.”

“My time is spent micro-managing our vendor.”

“The people assigned to my project are neither properly trained nor highly experienced.”

Their expectations for quality, reasonable cost, and efficiency were rarely attained. Yet, they continued to work with those same vendors.

Vital Mission to Transform Patient Lives

“Leaders are visionaries with a poorly developed sense of fear and no concept of the odds against them. They make the impossible happen.”

— Dr Robert Jarvik

We set out with the belief that we could create a different type of solution: providing unparalleled service, thereby making a difference to our employees, our clients, and the patients we served. We wanted to restore tradition in the outsourcing world, by leading the way as a global solution that actually delivered on its promises. We were inspired to bring precision and assurance to an industry that had been inundated with complexity and disappointment.

But as we took that leap, we quickly realized that changing a decades-old paradigm was going to be a bumpy, difficult journey. We had to restore optimism in the hearts and minds of the operational leaders, as well as within their organizations, and this required patience and commitment to our goals and mission.


“If you think you are too small to make a difference, you haven’t been in bed with a mosquito.”

— Anita Roddick

From the beginning, we recognized the importance of inSeption’s unwavering commitment to quality, open communication, honest efforts, and integrity. Our success would rely on our ability to build this organization with industry experts who take pride in their work, are empowered to make a difference, and remain focused on the human experiment in which we were participating. It is because of YOU that inSeption is able to provide our clients the competency, proficiency, and trust that they could not find elsewhere.

As I am provided an opportunity to reflect on some of the reasons behind the success of our company, it rarely goes any further than the accomplishments of this team and the services we provide our clients. I am convinced that your continued dedication will contribute to our collective prosperity. So, I say to each of you…THANK YOU!!


“Vision without action is merely a dream. Action without vision just passes the time. Vision with action can change the world.”

— Joel Arthur Barker

Meet the Partners

On September 1st, as inSeption celebrated its 9th year, Joe and Brian took a moment to share their memories of this incredible journey. (You won’t want to miss the bloopers!)


Awards and Recognition

Award
Award

In May, Dawn Niccum had an opportunity to present on the topic of Risk Management in clinical trials and clinical quality management systems at the virtual Model Agreements & Guidelines International (MAGI) Conference. You can take a look at the press release for Dawn’s presentation on Clinical Leader here.

In addition, she was awarded Metrics Champion 2020 by the Metrics Champion Consortium (MCC), which is a leading standards organization in the Clinical Research industry. This award was given in recognition of Dawn’s tireless efforts to advance the efficiency, quality, and effectiveness of Clinical Trials.

Congratulations Dawn!

MCC 2020 Champion

Where We’ve Been

Even through these tough times, inSeption continues to actively engage in remote conferences to connect with other industry experts. Take a look at a few of the conferences we’ve recently attended! If you happen to know of any future conferences that our clients will be attending and would be of interest to inSeption, please reach out to Adam McKinlay (amckinlay@inseptiongroup.com).

Recent Conferences

  • MAGI Conference: May 2020
  • Patients as Partners: August 2020
  • Clinical Document World: September 2020

Chief Medical Officer Summit 360°, October 2020

As part of the CMO Summit Conference, we were given the opportunity to put together a five-minute video for our virtual booth to best represent who we are. As a result, we shared the culture of inSeption Group!

Core Values

inSeption Initiatives

Hope Exists

Hope Exists is a consortium comprising like-minded individuals, organizations, and companies, all working together to deliver the full lifecycle of patient education, awareness, pre-screening, referrals, and management of clinical trials, but centered on the needs of each unique patient.

The group aims to empower patients to have more involvement in determining their optimal treatment plan, and to encourage all industry professionals to return to the foundational principles of clinical research: discover and develop new, superior treatment options for patients.

To learn more about Hope Exists, we interviewed Caitlin Horbacewicz, inSeption’s Director of Clinical Operations. Caitlin has played a key role in leading the creation of Hope Exists.

Hope Exists

What sparked the idea for Hope Exists?

Personally speaking, the 10 years that I spent working on the Sponsor side of the industry opened my eyes to many things, both positive and negative. I felt strongly that all of my experiences, challenges, accomplishments, and learnings were for a purpose: to help change the industry mindset to actually revolve around patients as individual people (exemplified through actions).

 

When do you think Hope Exists will…exist?

While timelines are still under discussion, we are targeting public outreach and awareness efforts to begin in late 2020 or early 2021, and the initial website/platform go-live by early-to-mid 2021.

 

How does Hope Exists intend to make a difference for patients?

By helping patients become their own advocates and equipping them with self-educational resources, and also providing 1-on-1 concierge support through our Patient Navigators, we will encourage more patient participation and empower them to have more control over their own treatment journeys.

 

How will Hope Exists and inSeption be tied together?

While Hope Exists is a separate entity from inSeption Group, team members across both organizations share the same passion to ensure that each patient is treated as an individual, and both are committed to helping patients gain access to the best treatment option(s) according to their unique circumstances. Joseph Arcangelo had the honor of collaborating with a prominent and inspirational patient advocate, Jamie Troil Goldfarb, and the 3 of us worked together to create Hope Exists. Jamie has gone through the treatment journey herself and knows first-hand what challenges patients encounter and the potential benefits of clinical trial participation.


Remote Based Monitoring

As many Clinical Research professionals are aware, source data is the initial data recorded within a clinical study, which may be captured electronically using direct data capture (direct entry or system integration) or using paper Source Documents (which are then transcribed into the applicable Case Report Forms). The “where” and “how” clinical research data is recorded are critical aspects of data integrity and regulatory compliance within clinical research trials. The decision regarding the method and process for data collection has regulatory ramifications in terms of how the data is handled, analyzed, and reported, how long it must be retained, and who has access to it. Source data may come from innumerable sources, such as digital thermometer readings, electronic medical record (EMR) entries, procedure and/or laboratory results, electronic patient-reported outcomes (ePRO) and questionnaires, or even hand-written notes on scrap paper.

To date, most of the Clinical Research industry has relied on CRAs (known within inSeption as Regional Site Managers, or RSMs) doing on-site visits to review this source data in person; however, the COVID-19 pandemic has spurred rapid changes due to site closures and restrictions. inSeption is actively implementing Remote Based Monitoring (RBM) solutions, including remote review of EMR, source data review in a “box” storage platform owned by the site, and videoconference “over the shoulder review” with sites. In addition, we are currently working with several potential partners to identify an “eSource” option for electronic source data capture to provide clients with alternative solutions, while ensuring that data integrity and regulatory compliance are maintained even in the absence of on-site monitoring visits for data review and verification. Our goal at inSeption is to find solutions for remote monitoring that continue to ensure the highest quality monitoring while reducing the time and cost for both sites and RSM’s.


Home Health Care

Home health spending has increased by 30% in just the last five years, and current projections estimate almost $187 billion will be spent on home health care by 2027. Factors such as the aging population, prevalence of chronic diseases, increased acceptance of home care among medical professionals, medical advancements, the longevity of life, increased utilization of home healthcare in clinical trials and most recently the COVID-19 pandemic have all contributed to significant growth of the home care business sector.

With inSeption’s mission to prioritize patients as our central focus, we believe that finding a Home Healthcare provider that we could partner with to build this segment of the business is a great opportunity and aligns directly with our mission. We are currently evaluating potential partners and hope to include Home Healthcare as one of inSeption’s service offerings by early 2021.

Corporate News

New Clients

inSeption is proud to announce our new clients as of June 2020! We work hard to partner our clients with the right inSeption team members for each project, as well as provide them with quality deliverables—every time.

Clients Websites Therapeutic Areas Projects
Allyx Therapeutics allyxthera.com Alzheimer’s disease Project Management, Medical Writing, QC and Regulatory Operations
Annexon Biosciences annexonbio.com Autoimmune and neurodegenerative diseases Medical Writing, QC
Aruvant Sciences aruvant.com Gene therapies for hematological diseases Medical Writing, QC, Regulatory Operations
Axsome axsome.com Small molecule treatments for CNS disorders Medical Writing, QC
BMS bms.com Oncology, hematology, immunology and cardiovascular disease Medical Writing, QC, Regulatory Operations
Disc Medicine discmedicine.com Hematologic diseases Medical Writing, QC
Gilead Sciences gilead.com Antivirals, Inflammatory Diseases, Oncology QC
Kura Oncology kuraoncology.com Oncology treatments using precision medicine and targeted therapeutics QA, SOPs
Madrigal Pharmaceuticals madrigalpharma.com Small molecule treatments for hepatic diseases QA, SOPs
Mapkure TBD Precision medicines for oncology Medical Writing, QC
Passage Bio passagebio.com Gene therapy for CNS disorders Medical Writing, QC, Regulatory Operations
SwanBio Therapeutics swanbiotx.com Gene therapy for neurologic diseases QA, SOPs, TMF

Marketing

Website

inSeption’s website is receiving a makeover! We’re updating the content and design to better represent our services and mission. Stay tuned for more information in the next newsletter.
For now, enjoy our new landing page as a sneak peek.

Under Construction

Blog-Coming Soon!

inSeption is also in the process of building our company blog! The blog content will include news about our company, our employees, the industry, and much more. We hope the blog will serve as an additional resource to those who can benefit from our service.

Watch this space for more information!


Social Media

We have received requests from a few of you to share the best way to repost inSeption’s social media posts. Following is a step-by-step guide to help you do just that!

  1. Navigate to the inSeption Group LinkedIn page
  2. Scroll to the post that you’d like to share
  3. Click the “Share” button (highlighted below)
  1. After you click “Share” you can begin typing a comment or simply click the “Post” button, which is located at the bottom right of the pop-up box.

Please reach out to Adam McKinlay (amckinlay@inseptiongroup.com) for more details!

Family News

On July 5th, Domenic DePascale, Resourcing Specialist in Clinical Operations, and his wife Lizz became parents to beautiful twin girls, Lucia Antoinette and Juliana Claire.

“I have always wanted to be a father, but the feeling of being one is greater than I ever could have imagined. Dad is the best job I’ve ever had (sorry inSeption). The twins are perfect in every way and my wife is a Rockstar. It has been the best adventure so far and I can’t wait to see what the future holds for these little angels.” –Domenic DePascale

The inSeption family sends heartfelt congratulations to the DePascale family. We wish them lots of love and joy on their journey together!

Please reach out to Adam McKinlay (amckinlay@inseptiongroup.com) if you have family news to share for the next newsletter!

Family News

Calendar Contest

inSeption is creating a company calendar to feature the best landscape photograph taken by you! We plan to print and distribute the calendar in 2022, so Joe and Brian will pick three winners every month for the next year, the employees who submit the best image that month will receive $100 Visa gift Card (and will be featured in that month of the calendar), $50 for 2nd, and $25 for 3rd! The winners will be announced in the following quarterly edition of the newsletter.

We ask that you submit images for the upcoming months by the deadlines listed below:

October: December 30th, 2020

November: December 30th, 2020

December: January 8th, 2021

All months following, images will need to be submitted by the end of the first week of the succeeding month

Ex: January: February 5th, 2021; February: March 5th, 2021

Here’s the fine print: The photographs must be your own—taken by you, with your camera. We won’t accept stock photos or borrows from social media. Also, please do not include people in your pictures—no selfies allowed. Instead, send us your most artistic landscape photos of any vista you choose: beaches, sunsets/sunrises, mountains, trees, or general nature. Please see the example below for inspiration. Photo image specifications are as follows: 1600×1200 pixels, > 300 dpi (or ppi) resolution, JPEG images, and landscape format. And finally, all 12 winning images will become the property of inSeption, so don’t send anything that you would like to use for professional purposes later.

We look forward to seeing your best Ansel Adams-like images!

Calendar contest

Please send your pictures to Adam McKinlay (amckinlay@inseptiongroup.com).

Employee Anniversaries

As we take time to celebrate the anniversary of inSeption Group, we would also like to recognize our employees’ milestones. We asked individuals whose work anniversaries occurred from October to December of this year to provide a short blurb about their time at inSeption Group.

Thank you to those who work hard every day to make inSeption’s vision a reality.

Patricia Riggs, HR Manager; Celebrating 9 years at inSeption Group

On 11/7, I will be celebrating 9 years with inSeption Group. I feel very fortunate to have been a part of this team from the very beginning and to witness all the growth and development along the way. What an amazing journey so far.”

 

Priscilla Lee, Legal Counsel; Celebrating 7 years at inSeption Group

In November 2000, I received a call from a Joe Arcangelo, trying to recruit me to re-enter the workforce for a small, new start-up company boasting to be the “next generation CRO.” After 13 years working for that “old company,” I got another call: “It’s about f*#’in time you got out of there!! So when can you start working for me?” …guess who? That was the beginning of my second journey with Joe Arcangelo!

I never intended to be at inSeption this long, and my husband has been telling me for 7 years now that I should retire. Well, that will become a reality at the end of this year as we plan to move to Hawaii. After working with Joe for 20 years now, I have no doubt that inSeption will continue to grow and flourish – and I am honored to have played a small part in its exciting journey.

I wish everyone the best of luck and try not to forget to look up and enjoy the crazy ride!

Mahalo to y’all!!

 

Deb Appello, Associate Director, Medical Writing; Celebrating 7 years at inSeption Group

After an exhausting 26-year career in big pharma, I was ready to retire but I felt that I still had much to contribute to drug development. I knew Brian for many years, and he gave me the opportunity to work at ISG. Not only was I welcomed with lots of love, I am now able to do what I do best and meet great clients (many of whom have become great friends) without the constraints of corporate America. I can truly say that working at ISG changed my life.

 

Tracey Radosti, Quality Control Specialist; Celebrating 5 years at inSeption Group

It has been almost five years that I have been working at inSeption Group and it often feels like only five weeks. I am grateful for my wonderful and supportive team and everything I have learned over the last five years.

 

Christine Reynolds, Senior Manager, Regulatory Operations; celebrating 3 years at inSeption Group

Confucius says: “Choose a job you love, and you will never have to work a day in your life.” I hope to play on this team for another 30 years (God willing). My colleagues are the best part! I am grateful to Joe and Brian for giving me the opportunity.

 

Dina Dunn, Associate Project Manager; Celebrating 3 years at inSeption Group

I am thankful for being a part of inSeption! It’s been great to experience the growth happening within the company and I’m grateful to have the opportunity to work with the best supportive team!

 

Kulwinder Kaur, Associated Director, Regulatory Operations; Celebrating 1 year at inSeption Group

I feel so lucky to be working at inSeption; there is no other place I’d rather be. Everyone I work with here is supportive, dedicated, hardworking, and eager to learn. I appreciate that everyone has bought into the company vision and works collectively towards the same goal of helping our clients and improving the quality of life around the world.

 

Laurie Meadows, Quality Control Lead; Celebrating 1 year at inSeption Group

I have enjoyed my time so far with inSeption tremendously. I’ve worked on several documents thus far, including the Myovant partnership, and will be leading the QC team for our Gilead partnership that is beginning. I hope to be with inSeption Group for the remainder of my career.

 

Stephanie English, Quality Control Lead; Celebrating 1 year at inSeption Group

Since joining inSeption in October 2019, I’ve been impressed with my colleagues’ dedication to their work and their friendliness. Also, I think our clients really benefit from our QC comments, which is a good feeling.

 

Stephanie Waller, Quality Control Lead; Celebrating 1 year at inSeption Group

“…and the way of love calls for us to be humanitarian…” —Bishop Michael Curry It has been my pleasure to work alongside the humanitarian efforts of inSeption Group.

Introducing inSeption’s Functional Areas

Quality Assurance

Did you know?

Our QA group is doing much more than writing SOPs and chasing compliance issues for our internal group, we also have been busy with several client projects:

  • Helping a group focused on cystic fibrosis research select, validate, and implement a new eTMF and Document Management System
  • Conducting a gap analysis and developing a Quality System plan for an emerging oncology company
  • Supporting the eTMF for a Gene Therapy company focusing on breakthrough therapies in hemophilia and Huntington’s disease
  • Developing SOPs and Quality System documents for companies with limited or no internal QA resource
  • Performing a Mock Inspection for a company currently preparing an NDA

Quality Assurance

Quality Management System Assessment, Development, Implementation

  • Quality System Documentation including SOP, Policy, and Associated Document Development
  • Gap analysis – Quality System, eTMF, Training, etc.
  • Vendor Qualification, Audits, Oversight
  • Training Development and Delivery (for the QMS<GCP, and Study Level)
  • Site Audits
  • Computer System Implementation support
  • Mock Inspections
  • eTMF implementation and oversight (Sponsor/Client system)
  • Change Management

Corporate Philanthropy

On September 26th, a team of inSeption volunteers participated in the St. Jude Philadelphia Virtual Walk/Run. St. Jude is a nonprofit organization whose mission is to advance cures, and means of prevention, for pediatric catastrophic diseases through research and treatment. Consistent with the vision of their founder Danny Thomas, no child is denied treatment based on race, religion, or a family’s ability to pay.

The team collectively raised $1,410. Prior to this event, inSeption made a corporate commitment to match 50% of the total funds raised by its employees. In addition, the company decided to make a one-time corporate donation of $1,500, for a total of over $3,600 contributed to this incredible organization!

We thank everyone who participated and donated to this event in an effort to end Childhood Cancer! If you have a charity that you feel strongly about and would like us to consider supporting, please reach out to Adam McKinlay (amckinlay@inseptiongroup.com).

St. Jude Walk/Run Activity Book

HR News

FSA – Flexible Spending Account

Open Enrollment for 2021 is September 1st through December 28th.

Our FSA plan allows for eligible employees to set aside a specific pretax dollar amount for unreimbursed medical, dental, vision, orthodontia, and dependent care expenses. If you have predictable out-of- pocket expenses, you may want to consider enrolling in the FSA.

Why should you participate?

Tax Savings – FSA deductions come out of your paycheck before most withholding taxes are computed, reducing your taxable income, and increasing your take-home pay.

Contact Patty Riggs, Human Resource Manager, for information on HR related topics.

Call for Content / Q&A

If you have ideas for future newsletter stories (including helpful Q&A), please reach out to Adam McKinlay (amckinlay@inseptiongroup.com). We would love for this newsletter to represent the people who make inSeption so special and look forward to sharing your ideas and stories!