PRESS RELEASE
Dulce Mariscal, PhD Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – March 3, 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 the addition of Dulce Mariscal, PhD, Clinical and Regulatory Affairs Project Lead. Dr. Mariscal earned her Doctor of Philosophy in Bioengineering at the University of Pittsburgh and was a post-doctoral researcher in the Bioengineering Department, Sensorimotor Learning Laboratory with advisor Dr. Gelsy Torres-Oviedo. After that program, she became a post-doctoral scholar in the Rehab Neural Engineering Lab within the Physical Medicine and Rehabilitation department, and assisted advisor Dr. Lee Fisher with an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA).
Photo by Jen Worley
Dr. Mariscal also holds a Bachelor of Science in Mechanical Engineering from the Universidad del Turabo in Puerto Rico, which she earned thanks to an athletic scholarship with the university swimming team. Outside of work, Dulce enjoys spending time with her family and taking her two dogs for long walks. Dulce also likes to stay active, so she usually runs or bikes around the city.
Alethea Wieland, President and Founder remarks, “Our firm’s reputation is built solidly on our engineering and problem-solving excellence involving quality assurance, risk management, clinical operations and regulatory strategy. Dulce has a well-rounded academic background and post-doctoral work to help spearhead our programs with key academic and military clients in translation to first-in- human projects.”
David Link, MBA, CRS CEO and Chief Quality and Regulatory Officer adds, “Dr. Mariscal is a great value add to our trials and human factors programs and, since she has first-hand experience with early bench-to-bedside projects, she understands the agility required to face the regulators in an early setting.”
About Clinical Research Strategies, LLC:
CRS is a specialty clinical CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, attorneys, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and sales and marketing 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, Functional Service Provider (FSP) models, selection and management of CROs, regulatory compliance strategy and submissions, QMS, EU MDR and GDPR, rescue trials, TMF, risk mitigation and remediation, training high-performing teams, staffing solutions, 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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Media Contact:
Ron MacDonald
Step2 Branding and Design
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+1 724.814.4067
Alethea Wieland, President and Founder
Clinical Research Strategies, LLC
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+1 724.272.1245
