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