Experience, a Collaborative Partnership
UNITY and Rho’s Answer to Mitigating COVID-19 Risk in a Complex, Fast-Moving Osteoarthritis Program
UNITY Biotechnology partnered with us to run a complex and fast-moving Osteoarthritis program with three active, concurrent studies across 25 sites and 218 patients when COVID-19 hit. Interim database locks were already scheduled four months away with final database lock deadlines looming close behind. The pandemic put that all on the line.
The UNITY and Rho teams had to pivot quickly to find creative solutions for site availability, patient retention, and remote monitoring that would ensure patient safety, data quality, and allow study progression to continue without delay – while following pandemic-related guidelines. Using a customized and decentralized multi-layered strategy, UNITY and Rho were able to successfully transition all three active studies in under four months, maintain integrity and ultimately meet critical database lock timelines.
3 studies were successfully transitioned in under 4 months, while maintaining pre-pandemic metrics for:
- Patient retention
- Recruitment and overall program timeline
- Database lock
UNITY Project Team Members
Vice President Clinical Operations
Akbar has over 25 years of experience in managing global clinical studies and high-throughput research operations. He has led the overall strategic planning, implementation and delivery of multiple clinical programs in multiple indications and disease areas. He has a collaborative leadership approach in managing studies while continuing to identify program risks, develop mitigation strategies and implement solutions to meet corporate goals. Mr. Khan is experienced in transitioning multiple programs from research to multinational global pharmaceutical studies. He received his BS in Biochemistry and Molecular Biology from the University of California, Davis.
Clinical Program Manager
Lauren has 10 years of clinical trial experience including working in academia and in industry. Her therapeutic areas of expertise include pediatric Hematology/Oncology, Autism and adult Immuno-Oncology. Most recently at UNITY Biotechnology, her focus has been on managing Osteoarthritis and Ophthalmology trials. She has built a strong foundation for managing many studies simultaneously and meeting overlapping deadlines and company milestones. Lauren received her BA in Psychology from University of California at Santa Cruz.
Rho Project Team Members
Nick Poulson, Ph.D
Senior Project Manager
With almost a decade of clinical trial experience, Dr. Nick Poulson has managed, monitored, and coordinated Phase 2 through Phase 4 clinical trials across various therapeutic areas, especially pain. Holding multiple roles across more than 5 osteoarthritis studies, Dr. Poulson currently serves as Senior Project Manager of an Osteoarthritis Program. Over the course of this program, Dr. Poulson was able to reduce enrollment timelines by 2-3 months by coordinating and guiding his team through a fast-paced startup timeline to ensure the activation of most sites before enrollment for each study began. Always giving 110%, Dr. Poulson prides himself on delivering…
Senior Project Manager
Fran Sawyer has over 13 years of industry experience including serving as a lead on a Vaccine, Cardiovascular, Pain, COPD, and Osteoarthritis trials. Her other study indications include high risk vascular disease and lowering LDL, atrial fibrillation, asthma, graft versus host, breast cancer, and sickle cell disease. She joined Rho in 2014 and is a seasoned leader with training and mentoring experience. Ms. Sawyer has a strong understanding of clinical trial management and delivery requirements that has allowed her teams to successfully meet data timeline deliverables for various multi-center trials. She is also adept in all aspects of GCPs, regulatory…
Clinical Team Lead
Alexa Bawden earned her Bachelor of Science (BS) in Clinical Research from the University of North Carolina at Wilmington. She has over nine years of clinical research experience across Phase 1 through 3 studies, in addition to one device study. Her research experience is in otitis media, open-angle glaucoma (OAG)/ocular hypertension, attention deficit hyperactivity disorder (ADHD), multiple sclerosis (MS), visual acuity, post-operative pain (following bunionectomy), osteoarthritis (of the knees), and Major Depressive Disorder (MDD). Ms. Bawden has been involved in overseeing the planning, design, execution, and monitoring of multi-center trials while providing leadership, mentoring and training to the clinical monitoring…
Rho has been an exceedingly and consistently reliable partner in our three pain centric clinical trials in OA, and a true extension of our team at UNITY.
Associate Director, Clinical Operations, UNITY Biotechnology
Take a journey through the challenges, creative approach, and real-world outcomes of UNITY and Rho’s collaborative partnership to keep three Osteoarthritis studies on track during COVID-19.
Decentralized trials are the new normal, demanding real-time answers that are developed as a result of experience, and a willingness to adjust and adapt to any situation. Contact our experts to learn more about how a collaborative relationship between Sponsor and CRO is critical to tackling challenges and keeping your program on track.