About Us
About Chimera Clinical Management
Chimera Clinical Management offers scalable, right-sized customized and turnkey solutions for clinical trial support. Our experienced clinical operations team consists of regulatory, quality assurance, project management, monitoring, and documentation management personnel. Together, we function as a scalable, efficient, responsive clinical operations department. Proven and process-driven, we uniquely leverage experience, training and technology.
Chimera Clinical Management is a clinical research consulting company offering a full range of services to global biotech, pharmaceutical, and device companies.
Chimera Clinical Management offers turnkey solutions for global project management, document management, regulatory oversight, and both traditional and electronic Trial Master File creation and maintenance.
Chimera Clinical Management provides full study life-cycle support designed to meet the needs of companies looking for high-quality, efficient, and agile clinical trial solutions.
Our unique clinical trial management system provides secure real-time support specifically designed for use by remote and diverse clinical teams. Our common operating methodology ensures open and secure communication, controlled and reliable document access, retention of institutional knowledge, and maximum efficiency.
In addition to clinical trial support services, Chimera Clinical Management also provides quality system build services, including SOP creation and revision, GxP auditing services, corporate training classes, and much more.
Our Project Management team has 50+ years of combined clinical research experience in drug, device, and other pathways. Our therapeutic areas of expertise are broad, including:
Therapeutic Area Experience:
- Cardiovascular Disorders
- COVID-19
- Crohn’s Disease
- Diabetes
- Endocrine Disorders
- HIV/AIDS
- Infectious Diseases
- Influenza
- Movement Disorders
- Multiple Sclerosis
- Nuetraceuticals
- Oncology
- Ophthamology
- Organ Transplant
- Respiratory Diseases
- Somatopause
- Vaccines
- Weight Loss
Experience Includes:
- Protocol Development and Implementation
- Clinical Monitoring
- Vendor Management
- DSMB Management
- FDA Submissions
- CAPA Planning and Resolution
- Management of Financial and Operational Controls
- Team Building
- Identification and Training of Personnel
- GCP and QA Auditing
- Quality Builds and SOP Development
- Wen S, Richardson M, Kito R, Stram D, Tada D. An Observational Study to Collect and Assess Tissue Samples from Subjects with One of Three Neoplastic Conditions (ANSWer). Blood (2020) 136 (Supplement 1): 44–45.
- Scadden DT, Doweiko J, Bernstein Z, Schenkein D, Luskey B, Stram D, Esseltine D, Levine AM. Combined Immunotoxin and Chemotherapy for Initial Treatment of AIDS Lymphoma. Abstract and poster presented at the 36th Annual Meeting and Exposition of the American Society of Hematology, 1994.
- 2022: Meet The Minds Clinical Research Webinar Series: Featured Panelist, Clora
- 2023: The Clinical Trials Guru Podcast #674: The Future of CROs
- About Donna Stram
Chimera Clinical Management History
1995
Stram Clinical Services was founded.
2014
Rebranded to Chimera Clinical Management and expanded services/staff to provide clinical monitoring and trial management.
2019
Expanded partnerships to ITS and Medidata Rave.
Today
Global clinical trials phases
I - IV.