Study Startup

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 Pharmaceutical, Biotechnology, Nutraceutical, Medical device and Ayurveda 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 we provides an assistance to 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
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