Services

Core Services Overview

Bioavailability & Bioequivalence

Our state-of-the-art infrastructure spread over 12,000 sq. ft. facilitates one stop centre for executing BA/BE studies:

  • 42 beds spread over 2 clinical units for simultaneous conduction of multiple studies resulting in quick turnaround time

Quality Control

  • Quality control planning to ensure 100% accuracy of critical variables
  • QC during process: manual review of critical data fields in CRFs
  • All activities and results are checked by a colleague statistician.

Medical Writing

Our expertise:

  • Qualified, trained & experienced team of statisticians, SAS programmers, pharmacokineticists, and medical writers provide high quality data analysis & statistical report writing in accordance with regulatory standards
  • Protocol preparation team holds strong experience in conducting clinical studies with medical or pharmacy background designed clinical studies

Bioanalytical Services

We offer extensive bio-analytical services in drug development by conducting analysis ranging from evaluation of drugs in samples to biostudies. Our bioanalytical department spread over 2000 sq. ft. which facilitates offering end to end bioanalytical support with team of qualified analysts. We have a successful track record of regulatory inspections /audits by the USFDA, EMA, MHRA, TGA, DCGI, ANSM,BfArM.

Quality Assurance

Our quality policy is to conduct business through self imposed Professional Ethics and Quality Management Systems. Synapse has more than 300 SOPs to regulate different research activities within the unit.

Supporting Services Overview

Regulatory Affairs

➢ IEC / IRB submissions and approvals
➢ BENOC and T-Licence Liaise and Approvals
➢ Constant communication with regulatory agencies

Project Management

At Synapse, we always strive to exceed sponsor's expectations by ensuring optimum communication and through co-ordination in each project.

➢A dedicated Project Manager (assigned to each account) ensures end-to-end management of every project and maintain timelines and deliverables.

 

Clinical Trials

Synapse has capability to design, conduct, monitor & report clinical trials of different phases such as Phase II – IV. Trials are conducted & managed by well experienced personnel’s with accuracy, adhering to quality standards & within specified timelines.

 

Contract Research

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Operations

Synapse has large data base of qualified, experienced & trained Investigators in various therapeutic segments such as Cardiovascular, Dermatology, Neurology, Oncology, Gastrointestinal, Respiratory, Antidiabetics and many more.

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