Symbio is committed to the success of our sponsor companies. Since 2002, we have managed over 200 Phase 1 – 4 clinical trials enrolling over 65,000 subjects in the US, as well as in other territories. Our attentive, collaborative, experienced and resourceful team members are dedicated to each project.
- The Project Management Group is made up of experienced project managers and senior project managers with backgrounds from small to large pharma and CROs. A project management team is dedicated to your study and provides complete team oversight, including strategic planning and milestone tracking throughout the project.
- Monitoring – Symbio Clinical Research Associates (CRAs) are located across the United States and are given regional monitoring assignments for efficiency and to reduce travel time. Symbio’s monitoring team is unsurpassed in years of experience. Over 90% of CRAs have more than 10 years of industry experience; 70% have over 20 years of experience. Our CRAs work with sites to make sure the protocol is followed, recruitment is on target, subject safety is paramount and the data is collected in a consistent and reliable manner.
- The Data Management Group provides oversight to all aspects of data capture throughout the project. From database design, validation, collecting paper or electronic case report forms, to efficient query process and edit checks, our data management group has over 40 combined years of data management experience. Their comprehensive knowledge of protocol requirements sets them apart in the industry enabling them to thoroughly review data resulting in quality data queries and edit checks. The data group works in conjunction with the project management group to assure timelines are met.
- Our Medical Affairs team is led by Symbio’s MD, Dr. Evyan Cord-Cruz. Our medical monitoring services include assisting the clinical team and investigators with clinical questions throughout the project. Dr. Cord-Cruz also provides SAE management services and review of the subject listings data. Our Medical Affairs team is also responsible for writing protocols, informed consent forms, investigators brochures and preparing clinical study reports in eCTD format.
- The Symbio biostatisticians have over 25 years of experience in the clinical research industry. They have been involved in all phases of clinical programs and carefully review objectives and endpoints to develop the statistical analysis plan. Their precise analysis of the data includes incorporating the tables and listings for the final programs and productions.
- Symbio has a dedicated site recruitment department who is always researching experienced sites and continually work to maintain our strong quality site relationships.
Partnering With Symbio
We form longstanding partnerships with our sponsors. A commitment to your success is our main objective. We are a dedicated, experienced, high quality team offering you:
- 100% owner involvement
- Extensive experience in dermatology, generic bioequivalence and topical formulations
- Highly trained and motivated personnel
- Close continuing relationships with clinical sites
- EDC for real time data
- Top line results possible within 1 week of database lock
- CDISC datasets
- Submission ready final clinical study reports
- Database of over 1,000 investigators and clinical sites