Our services

Clinical Data Management

  • Database design
  • Data Entry & Validation
  • Electronic Data Entry/ Remote Data Entry Log & tracking
  • Data Cleaning/ Correction Processes
  • Clinical Data review
    • Subject Level Data Review
    • Medical Data Review
  • Data Quality Review & Controls
  • Double Data Entry Verification
  • Database Lock & Archiving
  • Report Generation

Clinical Drug Development

  • BA/BE Studies
  • Phase I-IV studies
  • PK-PD Studies
    • Project Management
    • Site Management
    • Clinical Monitoring
    • Risk Based Monitoring
    • Remote Monitoring
    • Clinical trial Supply Management
    • Vendor Management
    • Feasibility studies
    • Study start ups
    • Quality compliance

Investigational Product Management

The availability and continuity of IP are the important things to be assured during a conduct of clinical trial. We involved in managing and assuring the IP stock, storage and deliverance to the support of a clinical trial site.

  • Preparation of Investigational Product Management Plan
  • Finalization and coordination with comparator procurement organisations
  • Finalization and management of labelling and packaging vendors
  • Ensure availability of site supplies as per recruitment and subject progression

Patient Recruitment and Retention

  • We ensure your site will reach enrolment goals in a timely and cost-effective manner with our customized patient recruitment services.
  • Our recruitment methodologies maximize participation while offering education and support to attract and retain the proper target population to your trial



Regulatory Affairs

  • Regulatory Document Writing/Submission Writing
  • DA/MAA/NDS/PMA
  • ND/IMPD/IDE
  • ubmission Ready: Preparation Ready For Sponsor to complete Full Publishing for Submission to Health Authority.
  • eport Publishing: Ready to submit to Health Authority



Medical Writing

  • Clinical Document Writing
    • Protocol Writing
    • Investigator Brochure Writing
    • Case Report Forms
    • Informed Consent
    • Patient Diaries
  • Safety Data Writing
  • Manuscript Writing
  • All the tools and templets required to conduct clinical study

Pharmacovigilance

  • Set up & Maintenance of Global safety database
  • Medical review of Case Report forms
  • Define/CRT Documents
  • Collection, Evaluation, Analysis and Reporting of Safety Information from All Sources Including Spontaneous Reports Of Adverse Events Of Marketed Drugs
  • Online Coding (MeDRA, WHO DDE) Of Adverse Events
  • Preparation Of safety Narratives
  • Preparation of safety Narratives. Preparation and Submission of Periodic Safety Update Report (PSUR) to Regulatory Authority.
  • Publishing Services Can be full Publishing or submission Ready, As Best Meets the Sponsor’s Needs
  • Briefing/Meeting Packages
  • Submission Ready: Fully Compliant Electronic Document Preparation ready For Sponsor to complete full Publishing For Submission to Health Authority

Experienced Team

Experienced, trained professionals’ team

DR Adam Billiard

Heart specialist

DR Adam Billiard

Medicine specialist

DR Fred Macyard

CHeart specialist

DR Justin Stuard

Heart specialist

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