Clinical Research Strategies
Clinical Research Strategies (CRS) is a Pittsburgh-based contract research organization and executive management consultancy dedicated to improving the performance of start-up and mid-size life sciences companies. With a focus on instilling fiscal discipline and reducing risks in clinical development, corporate affairs, and quality assurance programs, CRS provides tailored consulting and staffing solutions to navigate the complexities of regulatory pathways and ensure successful product launches. CRS is also committed to leveraging advancements in artificial intelligence and machine learning to enhance clinical research and regulatory processes.
Industries
Nr. of Employees
small (1-50)
Clinical Research Strategies
6400 Brooktree Court, Suite 240, Wexford, PA 15090
Expertise Areas
- Clinical trial management and monitoring
- Regulatory strategy and global submissions (devices, drugs, biologics, SaMD)
- Quality management systems and inspection readiness
- Risk management and product safety engineering
Key Technologies
- Electronic data capture (EDC) and eTMF systems
- EHR-to-EDC interoperability and clinical data integration
- Decentralized trial technologies (telemedicine, remote monitoring, wearables)
- Real-world data and real-world evidence (RWD/RWE) methodologies
Key People
CEO and Chief Quality & Regulatory Officer
Director of Clinical and Regulatory Affairs
Clinical Research Associate
Senior Clinical and Regulatory Affairs Scientist
Clinical Research Associate
CEO and Chief Quality & Regulatory Officer
Director of Clinical and Regulatory Affairs
Clinical Research Associate
Senior Clinical and Regulatory Affairs Scientist
Clinical Research Associate
News & Updates
Clinical Research Strategies is proud to be a member of the Central New York Biotech Accelerator (CNYBAC) Service Provider Network offering Regulatory/Compliance, Risk Management/Quality Systems, Startup Company Support, and University Support services.
Alyssa Harris, Clinical Research Strategies Manager of Clinical and Regulatory Affairs, represented CRS at MEDICA – the world’s leading trade fair for medical technology & healthcare in Düsseldorf, Germany.
CRS Clinical and Regulatory Affairs Scientist, Dr. Haley Fuller, presented 'Translating Biotech from Concept to Clinic' discussing strategies for traversing the clinical, regulatory, and quality landscape.
Alethea Wieland of Clinical Research Strategies helps beginners understand the fundamentals of medical device clinical trials.
Alethea Wieland, CEO and founder of Clinical Research Strategies, weighs in on the conflation of cost and value in the clinical research industry.
A case study exploring the role of AI in healthcare, particularly in neurology, and its implications for clinical research.
Clinical Research Strategies is proud to be a member of the Central New York Biotech Accelerator (CNYBAC) Service Provider Network offering Regulatory/Compliance, Risk Management/Quality Systems, Startup Company Support, and University Support services.
Alyssa Harris, Clinical Research Strategies Manager of Clinical and Regulatory Affairs, represented CRS at MEDICA – the world’s leading trade fair for medical technology & healthcare in Düsseldorf, Germany.
CRS Clinical and Regulatory Affairs Scientist, Dr. Haley Fuller, presented 'Translating Biotech from Concept to Clinic' discussing strategies for traversing the clinical, regulatory, and quality landscape.
Alethea Wieland of Clinical Research Strategies helps beginners understand the fundamentals of medical device clinical trials.
Alethea Wieland, CEO and founder of Clinical Research Strategies, weighs in on the conflation of cost and value in the clinical research industry.
A case study exploring the role of AI in healthcare, particularly in neurology, and its implications for clinical research.