News

Stacey King to Chair Session on "Risk Based Monitoring: It Takes a Village" at the 2020 Virtual SCDM Conference

Join Aperio Clinical Outcomes' Senior Director Data Management Stacey King as she chairs a session on "Risk Based Monitoring: It Takes a Village" at the 2020 Virtual Society for Clinical Data Management (SCDM) conference. With constant changes from updated regulations to new technologies popping like popcorn, it truly takes a village to raise a product from concept to market. During this session, Mrs. King and her panel of industry experts will evaluate how Risk Based Quality Management (RBQM) is more than just risk-based monitoring, but a comprehensive approach to evaluating and monitoring overall clinical trial risks. They will discuss how the various members of the village work together to form a holistic Risk Based Quality Management (RBQM) strategy.

These distinguished panelists will join Mrs. King for her session on September 15, 2020, at 11:15 am EDT:

  • Kelly Doyle, ePRO Project Manager, PRA Health Sciences
  • Po Nam Loo, Director, Clinical Data Management, MSD R&D (China) Co., Ltd.
  • Suzanne Kincaid, Chief Operating Officer, Aperio Clinical Outcomes

Register for the 2020 Virtual SCDM Conference and learn what works, what doesn’t, and how you can implement a successful RBQM strategy for your next medical discovery.

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Suzanne Kincaid Named to Distinguished 2020 PharmaVOICE 100 List of Most Inspiring People

Aperio Clinical Outcomes is thrilled to announce that Suzanne Kincaid, Chief Operating Officer for Aperio, has been named to the PharmaVOICE 100 list of Most Inspiring People in the life-sciences industry.

PharmaVOICE 100 is the only awards program to recognize individuals spanning all sectors of the life-sciences industry — from academia to nonprofit organizations to big pharma to emerging biotech companies to all types of innovative companies that provide molecule-to-market services in support of moving the needle to benefit patients around the world. The result is a dynamic mix of people across a range of disciplines who are making meaningful contributions in their fields of influence. This diverse group of individuals is also unique in that they represent a wide variety of functional areas — ranging from the clinic to the C-suite. The PharmaVOICE 100 issue recognizes its distinguished honorees across multiple categories each year. Suzanne was named to the Commanders & Chiefs category. According to PharmaVOICE, the forward-thinking leaders that are named to this category are strategically positioning their companies for success and inspiring their teams to achieve far-reaching goals as they navigate complex industry challenges.

According to Taren Grom, editor and co-founder of PharmaVOICE magazine, "When we introduced the PharmaVOICE 100 most inspiring people in the life-sciences industry more than 15 years ago it began a movement. Our goal is to capture that intangible measure of a person’s influence: inspiration. Each year, our community puts thoughtful consideration into distinguishing the individuals who are leading the charge in terms of inspired leadership, creativity, breakthrough science, corporate excellence, patient advocacy, mentorship and sponsorship, technology development, and so on — in short the individuals who are driving change and redefining the landscape of the life-sciences ecosystem."

When speaking of Suzanne's recognition, CEO Faye Woolf said "I couldn't be more proud of Suzanne. Her gift of leadership and passion for clinical research and helping raise up the next generation of clinical researchers is inspiring to all of us who work alongside her every day. What makes this recognition so special, is that we now get to share all of the great things that inspire us about Suzanne with the rest of the life-sciences industry!"

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Aperio Donates to the Food Bank of Central & Eastern NC In Recognition of #GivingTuesdayNow

Aperio Clinical Outcomes has made a donation to the Food Bank of Central & Eastern NC, in recognition of #GivingTuesdayNow. #GivingTuesdayNow, held on May 5, 2020, is a day of global giving and unity in response to the unprecedented need caused by COVID-19. By participating in a virtual food drive coordinated by the Food Bank, Aperio staff raised a total of $875 to help feed families in need.

The Food Bank has seen an enormous increase in demand for food since the COVID-19 crisis began, with spending on food growing from $55,000 to over $2 million per month. In addition, the Food Bank has distributed thousands of family-sized boxes, containing 20 meals per box, to go to the Food Bank’s disaster relief partner agencies – food pantries, soup kitchens and shelters – as well as some area school districts, and several Meals on Wheels chapters. The Food Bank is also supporting numerous Grab & Go Meals for Kids locations to help support families who traditionally rely on school lunch programs throughout the year.

Consider joining the movement by making a generous donation at foodbankcenc.org.

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Aperio Relocates to the Innovating American Tobacco Campus in Downtown Durham

February 13, 2020 – RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Aperio Clinical Outcomes, a leading clinical research organization (CRO), has relocated its headquarters to the American Tobacco Campus, a hub for innovation in downtown Durham, NC.

The American Tobacco Campus (ATC) sits at the heart of downtown Durham, which has become one of America’s most dynamic regions as it evolved from a once-thriving industrial center into a mecca for higher education, creativity, and medical and technological advancements. The legacy of the American Tobacco Factory, originally built in 1857, was restored over the last 20 years after being purchased by the Capitol Broadcasting Company in 2002. The revitalization of the campus has resulted in award-winning architecture and landscapes, with over a million people coming each year to the ATC for work and entertainment. It has become the home of some of the Research Triangle’s most progressive companies and now includes Aperio Clinical Outcomes.

“Aperio’s culture is based on innovation – we work with sponsors that have groundbreaking medical advancements in an industry that has continuous technological breakthroughs and is always finding new ways to evolve,” says Aperio Founder and CEO Faye Woolf. “It was essential that our new location be around like-minded organizations in an environment that shares our passion for innovation and developing medicines to improve patients' lives. The American Tobacco Campus was a clear fit, and we are so excited to be contributing to the pioneering advancements that have come from this innovative and eclectic campus.”

Says Adam Klein, Director of Strategy at Capitol Broadcasting Company, “We are honored for Aperio to be our newest tenants and are excited for their contributions to downtown Durham’s innovation. Throughout the Triangle region, there is no real estate option as unique as the American Tobacco Campus, with its blend of historic and modern as well as serene outdoor space. We know the ATC environment will contribute to the ongoing inspiration and innovation that Aperio is known for.”

View source on: https://bwnews.pr/31OgroL 

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Aperio's COO Suzanne Kincaid featured in "Conversations in Clinical Trial Readiness" Series by ArcheMedX

Suzanne Kincaid, COO of Aperio, was recently interviewed with Kelly Ritch from ArcheMedX as part of their “Conversations in Clinical Trial Readiness” series.

When asked about Aperio's plans for optimizing clinical development processes in the future, Suzanne says, "In 2020, our focus is going to be on more analytics and centralized monitoring. It doesn’t eliminate the need for on-site monitors; we will just use them more for the skills and strengths they have rather than having very highly skilled professionals checking transcriptions."

Suzanne also says, "I’ve seen a lot of changes in clinical trials in the past 25 years, and I’m really excited about the advances and the technology enabling them, but the human aspect – the relationships, the experience, and the job knowledge – can’t be overlooked."

Throughout the interview, Suzanne discusses challenges within the clinical trial industry, how Aperio hurdles those challenges, and how the rise of analytics and technology can help with trial efficiency while still keeping that human touch.  Click here to read the full interview!


Aperio Hires CAR-T Trials Expert Jonathan Yusi to Support Cell and Gene Therapy Studies

January 31, 2020 – RTP, NC – Aperio Clinical Outcomes, a leading clinical research organization (CRO), announced today that Jonathan Yusi, an expert in the coordination and management of cell and gene therapy clinical trials, has joined the company as Senior Clinical Trials Manager to support their biotechnology clients in the immuno-oncology space.

Yusi has been managing immune-based therapy trials for over seven years. Prior to joining Aperio, he was a program manager for CAR-T studies and oversaw the first CAR-T program at a large CRO. He has provided independent trial management consulting for CAR-T trials, and his expertise has resulted in lasting KOL relationships within the immuno-oncology space. In addition to his adoptive cell therapy knowledge, Yusi brings over 20 years of clinical research experience to Aperio, with a focus on trial logistics, management, and monitoring of targeted and immune therapies in oncology trials.

Says Suzanne Kincaid, Aperio’s COO and an oncology industry veteran herself, “FDA expects to see over 200 INDs for cell and gene therapies in 2020, so it is imperative that our biotech clients have expertise like Jonathan’s to manage their trials. He has a strong understanding of the complexities of cell and gene therapy studies and can break down the components for ideal study set-up. We are so excited to have Jonathan help our immuno-oncology clients as they explore these groundbreaking treatments.”

“Cell and gene therapy trials are a logistical maze, and one missed endpoint can be catastrophic to the study,” says Yusi. “These programs allow me to utilize everything I’ve learned about clinical research and oncology, and my medical and scientific background brings an understanding to the science behind the treatments. The bulk of my career has involved oncology trials, so as the treatments have evolved and become more personalized, my experience has evolved as well. These are life-saving breakthroughs, and I’m happy to bring this experience to Aperio and our immune-based therapy clients.”

View source on: https://bwnews.pr/36LPVNA

About Aperio Clinical Outcomes
In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Aperio Taps Business Development Expert Heather Andrews to Drive Growth in Medical Device Services

December 3, 2019 - RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Aperio Clinical Outcomes, a leading clinical research organization (CRO), announced that Heather Andrews has joined the company as Director of Business Development to help drive growth in the medical device space.

Heather Andrews has over 19 years of experience in the cardiovascular device field. A former Medical Device Representative, Sales Manager and Director of Business Development, Heather brings with her a wealth of knowledge in clinical device trials. She maintains a large network of relationships in the medical device industry and cardiovascular space, enabling engagement of well-respected KOLs and industry experts. Her strong partnerships with her clients has enabled Heather to establish an unparalleled track record of repeat and referral business.

“We are thrilled that Heather joined our team to help lead the growth of our medical device division,” says CEO and Founder Faye Woolf. “The device industry is growing exponentially, and a large percentage of these companies are small and need help navigating the pathways from development through commercialization. Heather’s extensive network coupled with her ability to establish solid partnerships will enable Aperio to expand our medical device client base and bring more life-improving, lifesaving medical devices to market for patients.”

According to Heather, “Losing my father to coronary stent thrombosis has been a passionate driver for me to bring innovative solutions to the cardiovascular medical device community. I am honored to join forces with an organization like Aperio, where the average industry tenure of the colleagues on my team is over 15 years. I regularly encounter countless medical device companies who need the operational expertise, as well as the agility, transparency and responsiveness of a partner like Aperio. Together, we can help address the needs of medical device companies, which will enable Providers to offer more lifesaving solutions.”

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

View source on: https://www.businesswire.com/news/home/20191203005681/en/Aperio-Taps-Business-Development-Expert-Heather-Andrews

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Aperio Clinical Outcomes Experts from Clinical Data Management and Programming to Present at Medidata NEXT 2019

Two of Aperio Clinical Outcomes experts from Clinical Data Management and Programming will present two innovative panel presentations this week at Medidata NEXT 2019. Both panels will take place on Tuesday, November 12th in the New Models for Clinical Development & Drug Approval track.

Tuesday, November 12th, 2:30-3:10 pm
Considerations for Designing Your Virtual Trial: Lessons Learned from Data Management
Aperio Director Data Management Stacey King

Uniformity and standardization is critical within the clinical trial landscape. Data collection and reporting for clinical studies is evolving through implementation of new technologies that allow for direct patient data collection and direct access to electronic medical records. A great benefit for utilizing new technologies is increased accuracy and reduction of data entry redundancy. As the paradigm shift ramps-up, it is vital for clinical research professionals to become aware and be involved in developing processes that encompass these new technologies. However, how often do we take that notion too far and put ourselves or processes in strict requirements that do not allow for creativity or intuitive solutions and tools to help us get to the goal we need to achieve? Mindful proactive planning and analysis must be performed to get the maximum benefit from patient data collected from personal devices. This presentation will share real-world experience providing insights of why careful planning is critical in the name of standardization when using a single platform as the data source for multiple applications (Clinical Data, Safety Data, ePRO, Randomization, Trial Supply, Imaging, etc).

Tuesday, November 12th, 3:40-4:20 pm
The Benefits of a Flexible Database Design for Today’s Complex Clinical Trials
Aperio Senior Clinical Programmer Brian Stoddart

Clinical trials have become more complex than ever. Whether it is planning for multiple Investigational Products (IPs), incorporating an adaptive study design, or managing multiple protocol changes, it is important to implement a database design upfront that will allow for downstream changes to be made to the database quickly, efficiently, and with minimal impact to the existing data.

During this presentation, data management and data programming experts will discuss how flexible database designs present a proactive solution for managing complex trials. Attendees will learn how allowing for fluid data flow can be ideal for studies that will experience numerous changes over the life of the trial, and how this proactive approach provides for easy database modifications with little to no impact on existing data. Using visual representations of best practices, presenters will discuss the benefits of a flexible database design, including allowing for new protocol visits, customizing forms for allowance of additional assessments, and seamless reconfiguration of study events. Attendees will be able to take what they have learned and apply this design model not only to their next initial build, but if necessary, also as a midstream option for their complex clinical trials.

Aperio is a proud sponsor of Medidata NEXT 2019.

To learn more about Medidata NEXT, click here. Alternatively, contact Aperio to learn how we can support your organization’s clinical data management and trial technology needs.


Aperio Continues Strategic Growth With Cari Kniola as Director of Corporate Strategy

October 24, 2019 - RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Aperio Clinical Outcomes, a leading clinical research organization (CRO), has appointed Cari Kniola, Director of Corporate Strategy, to lead Aperio’s strategy for their existing and continued growth.

Kniola has over 20 years of clinical research experience in the medical device and pharma industries, ranging from a clinical research associate through project management of global studies at both sponsor companies and CROs. This experience is combined with an appreciation for Aperio’s culture and the need to preserve it as the company continues to grow and evolve. This strategic growth occurs as Aperio continues to match pace with a clinical research industry experiencing emerging technologies, novel treatments and an ever-changing regulatory landscape. Kniola will lead through oversight of proposal and marketing strategy, strategic business development and service partnerships.

Says Faye Woolf, Aperio’s Founder and CEO, “We want to make sure to continue to grow Aperio in a way that maximizes our potential while being true to who we are, all the while providing our services with the utmost quality and integrity. We are so fortunate to have Cari’s natural inclination towards strategy and creative solutions coupled with a vast background in the industry to ensure we maintain our core principles as Aperio makes its mark in the industry.”

“My entire career has been involved in clinical research, and I thrive on the creative process and seeing strategic visions come to fruition,” says Kniola. “I am excited to take both my ‘real world’ experience and my innate skills and use them together to help strategize the growth of Aperio. We have a team of people at Aperio who are passionate about what they do, with an amazing depth and breadth of experience in clinical development. With our high caliber teams, our culture of quality and transparency, and our ability to evolve as the industry evolves, the possibilities are limitless for Aperio’s continued growth as an agile and innovative CRO services provider.”

About Aperio Clinical Outcomes
In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: www.aperioclinical.com

View source on: https://www.businesswire.com/news/home/20191024005101/en/Aperio-Continues-Strategic-Growth-Cari-Kniola-Director

Aperio Clinical Outcomes Contact:
Heather Newbold: +1 919-604-5704
[email protected]


Aperio Will Bring Together a Panel of Experts at LaunchBio to Discuss Preparing for Medical Device Trials

Panel Presentation Will Feature Top Medical Device Experts from Aperio Clinical Outcomes, JD Lymon Group, Brooks Medtech, LLC, and NuPulseCV, Inc.  

Aperio Clinical Outcomes, a clinical development organization headquartered in Morrisville, NC, will moderate a panel presentation titled "Begin With the End in Mind: Preparing for Your Medical Device Clinical Trial" at LaunchBio, Inc. on Thursday, November 7, 2019.

Whether it is to support a Premarket Approval (PMA), 510(k), or post-market strategies, your clinical trial is a crucial next step in the life of your medical device. Understanding the multiple facets necessary to consider in the clinical development process will provide you with a holistic view of the road ahead, and allow for realistic short- and long-term planning for your device development and commercialization.

Join our presentation and hear from a panel of industry experts in medtech development as we discuss what to keep in mind when moving towards a medical device clinical trial, including:

  • Regulatory pathways
  • Reimbursement planning
  • Study design considerations
  • Operationalizing your clinical trial

The panel is scheduled to take place from 4:15 - 5:15 pm at the Chesterfield Building in downtown Durham and will include a Q&A time with the panelists and ample networking opportunities afterward in the main room. Cari Kniola, Director of Corporate Strategy at Aperio Clinical Outcomes, will moderate our distinguished line-up of panelists:

Chris Lyle, MS
Partner
JD Lymon Group

Steven Brooks, MD, MBA, FACC
Principal
Brooks Medtech, LLC

Sonna Patel-Raman, PhD
President
NuPulseCV, Inc.

LaunchBio takes place from 4:00 – 7:00 pm at The Chesterfield in downtown Durham. Aperio’s panel is scheduled for 4:15 – 5:15 pm.

To learn more or to register to attend LaunchBio, click here.