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|
Syncorp Health announces a significant milestone on receiving approval on 20-07-2020,as a Start-up recognized by the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India.
Syncorp Health announces significant milestone - strategic tie up with Research Mentor South Korea to expand Clinical Research Services.
Syncorp Health worked with American Megatrends India (P) Ltd to clear the 510K substantial equivalence review by USFDA for BT4 (K182401).
Syncorp Health successfully supported the Sponsor in weight Management & Wound Healing product CT & obtained approvals from MFDS, South Korea.
Syncorp Health moved to a dedicated world class CRO facility at Bangalore.
In FY 18-20, Syncorp Health successfully conducted 30+ Medical Devices Clinical Validations.
In FY 18-20, Syncorp Health successfully conducted 20+ Nutraceutical and Ayurvedic Clinical Trials.