Ohio Clinical Trials offers a broad range of services for Phase 1 through 3 clinical trials. In addition to providing a 50-bed facility, a principal investigator with more than 20 years of experience, and highly trained staff also with decades of experience, we offer an independent medical monitor with more than twenty years of experience, ready access to experts in a wide range of medical specialties, and independent clinical research associates (CRAs), data managers/biostatisticians, and medical writers, all with extensive experience.
The Clinical Operations Team of Ohio Clinical Trials, Inc provides customized services to fit all your needs, including not only CRAs but also Project Managers well versed in planning, implementing, monitoring, and managing the clinical component of your trial.
You will be assigned an experienced Project Manager who will serve as your primary liaison and will collaborate with you to customize the services you will require from study start-up to final report. Our Project Managers are responsible for ensuring on-time, within-scope quality deliverables.
Our independent CRAs will ensure that your trial is conducted according to ICH/GCP guidelines; FDA, CFR, and local regulations; and sponsor and site SOPs. The CRA is responsible for performing the initiation, interim, and close-out visits and works closely with the study team to ensure quality data and the protection of human subjects’ rights, safety, and well-being.
Data management, biostatistics, and medical writing include the following services:
- CRF and eCRF design
- EDC building and maintenance
- EDC training
- Database cleaning (query management)
- Medical coding
- SAE/AE reconciliation
- Management for data from other source
- Clinical trial and clinical program design
- Sample size (power) calculation
- Statistical analysis plan generation, including mock up tables
- Statistical analysis for individual studies
- Exploratory analysis
- Data mining
- Meta analysis
- Integrated summaries of efficacy (ISE) and integrated summaries of safety (ISS)
- SDTM and ADaM generation and conversion
- CDISC‐compliant NDA submissions
- Investigator brochures
- Integrated clinical and statistical reports (ICSRs)
- Abstracts and publications