PRESS RELEASE
Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC to Support Two ARPA-H Programs with Carnegie Mellon University
Pittsburgh, PA – October 20, 2025. Clinical Research Strategies, LLC (“CRS”), a Pittsburgh-area-based, US-owned and operated clinical contract research organization (CRO) and executive management consultancy for the life sciences industry is pleased to announce our support of two ARPA-H Programs with Carnegie Mellon University (CMU).
CRS will provide clinical and regulatory support working directly with Burak Ozdoganlar, professor of mechanical engineering at CMU, who leads the Biointegrated Implantable Systems for Cell-based Sensing and Therapy (BIO-INSYNC) project as the principal investigator. The initiative is part of a $42M award within the ARPA-H REACT program to accelerate the development of implantable, cell-based bioelectronic devices that deliver patient-specific therapy and monitor disease status, for conditions like hypothyroidism and hyperthyroidism, in real-time.
In addition, CRS will provide clinical and regulatory support to Rebecca Taylor, professor of mechanical engineering at CMU, who leads the ARPA-H Platform Optimizing SynBio for Early Intervention and Detection in Oncology (POSEIDON) program. The total POSEIDON award is $147M, and the local CMU portion is $26.7M which aims to develop sensitive and specific first-in-class, at-home, over-the-counter, synthetic Multi-Cancer-Early Detection (MCED) tests to identify 30+ Stage 1 solid tumors using only breath or urine samples.
CRS is proud to be a value-add stakeholder in the Pittsburgh life sciences ecosystem that helps attract funding for some of the most innovative technologies with the aims of solving the biggest challenges in disease detection and treatment and improving the lives and outcomes of Americans.
Read more about CMU
https://engineering.cmu.edu/news-events/news/2025/10/01-cancer-detection.html
Read more about ARPA-H
https://arpa-h.gov/explore-funding/programs
About Clinical Research Strategies, LLC:
CRS is a specialty clinical CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and risk management teams to take on the biggest challenges for start-up, mid-sized, and large life sciences companies, many of whom are developing novel, first-in-class drugs, biologics, diagnostics and medical devices, or software as a medical device (SaMD). Service areas are clinical trials; regulatory compliance, strategy and submissions; QMS, product requirements, IFU; EU MDR and GDPR; rescue trials and trial master files; risk management, mitigation and remediation; Human Factors; training high-performing teams; staffing solutions; and real-world evidence (RWE) and decentralized trials.
Indications represented are Aging, Biosensors, Cannabis, Cardiovascular Disease, Central Nervous System, Critical Care Medicine, Gastroenterology, Genetics, Infectious Disease, Immunology, Men’s Health, Metabolic Disorders, Microbiome, Neonates & Pediatrics, Neurology, Oncology, Ophthalmology, Opioid Abuse, Orthopedics, Pain, Precision Medicine, Rare Diseases, Radiology, Regenerative Medicine, Respiratory Diseases, Sleep, Women’s Health, Wound-Healing.
CRS is an approved sub-contractor for the NIH, DoD, and DARPA. CRS is affiliated with MTEC and is a Spoke Member of ARPA-H.
CRS requires persons to be authorized to work in the United States and to undergo a background check prior to becoming employed. CRS is an inclusive employer and does not discriminate in employment on the basis of race, color, religion, sex, gender identity, national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, education, membership in an employee organization, parental status, military service, vaccine status, or other non-merit factor. CRS does not tolerate censorship, surveillance, bullying, intimidation, retaliation, discrimination, or harassment of any kind.
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