Clinical Trial Support

We care life of human being & always strive to make it healthier by conducting ethical clinical research. Our industry-standard, validated SAS and data management system, compliant with ICH GCP guidelines and 21 CFR Part 11 regulations is a guarantee that you will always be provided with data of the highest quality.

We work in adherence to all regulatory guidelines in execution of successful clinical trial to support Pharmaceuticals, Biotech & Medical Devices companies. We offer end to end services or part of the activity to complete the trial or research successfully.

Medical & Scientific Writing

Having experienced team in Medical Writing makes us strong in;
  • Clinical Study Report
  • Clinical Trial Protocol
  • Informed Consent Document
  • Investigator Brochure
  • BA/BE CSR
  • BA/BE Protocol
  • Medico-Marketing documents
  • Clinical Overview (2.5 CTD)
  • CO Addendum
  • Non-Clinical Overview (2.4 CTD)
  • Safety narratives
  • SmPC
  • News Letter
  • Content Writing
  • Academic Writing

Clinical Data Management & Biostatistics

  • Data Management Plan
  • Paper Case Report Form (CRF) Design/ EDC
  • Database design and Data Validation plan
  • Quality control testing of database
  • Data entry
  • Medical Coding - MedDRA
  • Data Validation and Query Management
  • Central laboratory data import
  • Data lock, audit and export (SAS, ASCII, etc.)
  • Statistical Consulting & Analysis

Clinical Operations & Project Management.

  • Site Identification
  • Site Qualification and Initiation
  • Regulatory Document Preparation and Collection
  • Budget and Contract Negotiation
  • Investigator Meeting Planning and Presentation
  • Site Personnel Training
  • Interim Site Monitoring
  • Clinical Study Material Accountability
  • Site Termination

Pharmacovigilance:

  • PSUR /DSUR/PBRER/PADER writing
  • Safety Reports
  • RMP reports