Full-Service CRO

We understand that significant investment goes into product development and research.  We are purpose driven and provide solution for smarter, efficient and faster trial by focusing on your objectives, engaging the right experts and maximising resources.
We help you plan, design, manage and execute clinical trials.
We have completed numerous clinical trials in the ophthalmic field successfully; ranging from single site or multi-site; dispensing or non-dispensing; from early phase to post marketing.
Our services are customized to your purpose, budget and timelines and can include:

Study design 
  • Study design outline
  • Planning, budgeting, timelines
  • Clinical Investigation Plan (Protocol) development
  • Sample size calculations
  • Statistical Analysis Plan (SAP) development
  • Case report form design (eCRF)
  • Patient Instruction Sheet (PIS), Informed Consent (IC)
  • Preparation of Manual Operating Procedure

Study administration
  • Site selection (identification, recruitment, training, set up)
  • Investigator agreement and training
  • Preparation of documentation for regulatory submission
  • Ethics Committee approval (IRB / IEC etc.)
  • Registration of clinical trials (ISRCTN or clinicaltrials.gov)
  • Study initiation
  • Monitoring (sites, Adverse Events)
  • Study product reconciliation and disposal
  • Coordinate payments
  • Tracking study progress
  • Study document maintenance during the study
  • Study Reporting (interim, final reports, IRB/IEC)
  • Study document archiving
  • Close out

Data Management
  • Electronic data collection which is fully compliant with FDA CFR 21 part 11 for electronic data capture (EDC)
  • EDC validation
  • EDC implementation at site level
  • Site training and qualification in the use of the EDC
  • eCRF completion and query resolution with full audit features
  • Data storage
  • Data audit
  • Data management and database lock
  • Data analysis
  • Database closure.