The relationship between the site and CRO during study start-up is an important factor in creating a successful study outcome.
In the ever-changing global and local regulatory landscape, the key to fast track the regulatory approvals for clinical trials is based on expertise, understanding and ongoing professional relationships with regulatory personnel in each country.
Syncorp Health regulatory team consists of local staff with a deep understanding of that country’s regulatory requirements, we constantly monitor the regulatory environment of the Biopharmaceutical, Biotech, Medical device, Nutraceutical, Ayurveda, Probiotic and Diagnostic industries and we keep track of changes in all local legislation, guidelines and regulations.
Syncorp Health regulatory team will work with a sponsor’s Regulatory team to develop the strategic regulatory plan for the study and identify the best sites to be involved and assist to negotiate the site contracts and as well as we provides an assistance to the sponsor to working with regulatory authorities coordination and ethics committees.
We offer a comprehensive portfolio of services which can be tailored to meet the customer needs | ||
Clinical Operations | Therapeutic Area of Experience | Site Feasibility |
Site Selection | Study Startup | Patient Recruitment |
Site Services | Project Management | Site Monitoring |
Data Management | Biostatistics & Programming | Medical Writing |
Regulatory Services | Safety Services | Quality |
Consulting Services | Vendor Management | Technology |