The Center for Pediatric Clinical Development (CPCD) is comprised of 11 dedicated staff members who share diverse healthcare and research backgrounds. The CPCD is an agnostic group serving all of PRA’s pediatric needs in a multitude of capacities. Dr. Mark Sorrentino, who leads the CPCD, created a pediatric collaboration team (PCT) to support the continued success of PRA’s CPCD.
What makes PRA stand out from other CROs? We have a select, cross-functional group of dedicated staff with a passion for pediatric clinical research. Hear from members of the Pediatric Collaboration Team as they share their experiences and stories in our latest blog post.
Heather Peterson, Pediatric Strategy Liaison for the CPCD, facilitates the PCT with the experience and expertise of her fellow CPCD members. She describes the PCT as a “cross-functional team dedicated to advancing pediatric development and supporting efforts to bring approved medical treatments to children.”
The PCT consists of PRA staff with experience in all facets of pediatric clinical trials, including, but not limited to:
- Project management
- Clinical operations
- Medical monitoring
- Therapeutic expertise
- Regulatory affairs/strategic regulatory affairs
- Safety and pharmacovigilance
- Patient experience
The PCT provides quick access to PRA’s pediatric expertise across all functions. This allows for seamless integrative services and the ability to focus on each aspect of pediatric clinical development. Peterson states that the PCT is “a true differentiator because of the consistent cross collaboration and collective determination to reach a common goal—bringing approved medicines and treatment to children.”
The result of this interconnected, inter-departmental approach is a flexible, agile team equipped to handle all pediatric studies that come their way.
PCT team members elaborate on what it means to be a part of the PCT here at PRA.
Pediatric Strategy Liaison
My role within the CPCD is to provide a strategic review of a given protocol and study design to clients, ensuring it’s realistically aligned with the given age and expectations of participation. As a Pediatric Strategy Liaison (PSL) for the CPCD, we always consider the safety of pediatric participants and how the trial schematics will involve the entire family circle. Understanding the patient journey is crucial as there are many intricacies with pediatric trial participation, much different than encountered with adults. Pediatric clinical trials require a partnership between the site, the parent/legal guardian, and the patient to ensure enrollment, retention, and that successful completion is obtained. Many factors must be considered such as direct support with transportation to clinic visits, time away from school and limiting disruption of normal daily activities of children, their siblings, and caregivers, obtaining parental approval, and participant assent. These are a few of the considerations a PSL will focus on when reviewing a protocol and study design.
The impact this has on PCT members can be displayed differently, based on the PRA function of members. Weekly collaboration creates an engaged community that allows for awareness of opportunities and perspectives from contributing members. For example, if the need for regulatory expertise arises, there’s a member present to provide comment or direction for appropriate proactive measures or needed mitigation suggestions.
All members of the CPCD are active participants of the PCT.
The extreme diversity and experience of our members. The PCT includes multiple facets of expertise within PRA, bringing together therapeutic, functional, and operational perspectives. The PCT provides instant points of contact and reference, which I believe is a benefit for all members. This in turn provides our clients with diversified perspectives.
A day for me as a Pediatric Strategy Liaison requires protocol reviews, meetings, and researching literature. No one day is the same and does not always go as planned. We wear many hats within our center and every day is a new, exciting challenge. Daily success requires adaptability, commitment, and dedication to reach intended daily goals.
The PCT’s structural makeup is a core group of dedicated team members that truly desire to participate and collaborate with one another. All members within the PCT share values that will have long-term, lasting benefits for children, their families, and generations to come.
The PCT is a true differentiator because of the consistent cross collaboration and collective determination to reach a common goal—bringing approved medicines and treatment to children.
Heather Peterson | Pediatric Strategy Liaison
Manager of Clinical Operations, Clinical Team Managers Clinical Delivery
I oversee the clinical operations in the North American Clinical Team Managers (CTMs) group at PRA. As a functional manager, I’m responsible for supporting my team to produce quality clinical deliverables, including the final, clean patient database and the Trial Master File (TMF). I supervise Clinical Team Managers (CTMs) and support them in their interactions with sites, sponsors, and vendors.
I support troubleshooting issues, keep track of project metrics, and bridge the gaps between therapeutic teams.
I heard about the Pediatric Site Network (PSN) while I was a CTM. I expressed interest in being a relationship manager for a children’s hospital and I was asked to join the team. I’m always looking for opportunities to meet and collaborate with new people across the organization.
The PCT is valuable in tackling the complex issues inherent in pediatric trials. We all fill in each other’s knowledge and experience gaps. We need cross-functional collaboration to make headway on these issues—no one person could be an expert in every therapeutic area.
Additionally, the PCT is a tremendous asset to PRA. We all make better, collective decisions when we hear the perspectives of others.
On a typical day, I spend a lot of time on the phone. There are 14 CTMs on my team who together have about 12-15 protocols. There’s a lot of switching back and forth, discussing the studies we’re focused on, and finding creative ways to keep our projects moving forward.
We provide problem solving at all levels by discussing issues ahead of time. In operations, we have such limited access to other people’s perspectives. On the PCT, we are ambassadors for our own functional areas and are able to bring PRA’s diverse experience back to our individual teams.
I love hearing updates about things that are going on at PRA pertaining to research for children that are outside of my area of specialty.
Jen Davis | Manager of Clinical Operations, Clinical Team Managers Clinical Delivery
Joanna Perkins, MD, MS
Medical Director, Hematology/Oncology - Medical Affairs
I am a pediatric hematologist-oncologist and serve as a medical director and therapeutic expert for PRA Medical Affairs. I am board-certified in pediatrics and in pediatric hematology-oncology. My role in the PCT is primarily to serve as a disease expert in hematology and oncology, as well as to be a part of ongoing updates with pediatric trials that PRA conducts.
After joining PRA in 2018, I learned about the PCT through colleagues in my division, and subsequently started attending the meetings.
For me, the best thing about the PCT is the amazing group of multidisciplinary experts. I appreciate the discussions we have when reviewing trials, the diverse perspectives, and experience outside of my therapeutic focus. I love hearing updates about ongoing PRA pediatric studies in other specialties. I really appreciate Heather’s leadership, our in-depth discussions, and the weekly focused topics. Heather often invites outside speakers on a variety of pediatric-related topics. I enjoy working with this group in particular because there’s such a commitment to and focus on children.
My responsibilities as a PRA medical monitor vary significantly from day to day, and are individualized to each specific study. In general, medical monitors provide oversight in the interest of protecting the safety and welfare of clinical trial participants and the medical and scientific integrity of the trial. We evaluate eligibility forms, for example, for patients being considered for enrollment in clinical trials. We respond to medical questions from research sites and provide review of the studies’ medical and safety data. We provide therapeutic training to the study team members.
Heather invited a patient with a bleeding disorder to speak to the group on her experience and why she considers it so important to participate in research and clinical trials. Hearing her story and how she advocates for other patients made that experience particularly special and brought the importance of what we do to a really personal level.
We are unique compared to other CROs in that we have such a large, dedicated group of people from multidisciplinary backgrounds that are committed to pediatric research. The passion and the compassion of this group of people are exceptional.
The passion and the compassion of this group of people are exceptional.
Joanna Perkins, MD, MS | Medical Director, Hematology/Oncology - Medical Affairs
The PCT is filled with dedicated, passionate, and bold members with varying areas of expertise and experience. The collaboration and cross-functionality of the team allows for a safe space where knowledge and ideas can be shared, allowing PRA to continue executing studies that save or enhance children’s lives.Learn more about our Center for Pediatric Clinical Development
We support the phase II-III clinical development of niche treatments, blockbuster drugs, and biosimilars that help save lives.
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