Site Evaluation
- Continually Identifying Potential Sites And Investigators Nationwide
- Feasibility Assessment
- Large And Diverse Patient Population With Positive Attitude Towards Clinical Research
- End To End Site Management
- Monitoring And Audits/Site QA
- Maintain Clinical Trial As Per Regulatory Requirement
- Weekly Reporting To Sponsors Or CROs
Independent Auditing
- Process Audits (Sponsors, CROs)
- Compliance Audits (CROs, Investigator Sites)
Medical Writing
- Preparation Of Study Reports, Manuscripts, Posters, Abstracts Etc.
Data Management
- Preparing Data Entry Application
- Set Up Design And Optimize Clinical Database
- Management Of Electronic Data Applications
- Data Tracking, Cleaning, Uploading And QA/QC
- Data Generation For Analysis
- Creating Reports
- Query Management
Regulatory
- Managing Entire Approval Process
- Preparation Of Regulatory Dossiers
- Follow Up With Regulatory Authorities
Ethics Committee
- Expedited EC Approval
Biostatical Services
- Statistical Plan And Analysis
- Statistical Reporting
Translation
- What We Translate: CT Reports, ICFs, Patient Information Sheet, CRFs, Study Results And More.
- Our Aim: Remove language and cultural barriers and assuring that Non-English speaking study subjects get the same high quality information that the English-speaking subjects get.
- Moreover, a poor quality translation can lead to increase in total cost of trials, delay in marketing, lawsuits or rejections by regulators and also jeopardize the safety and efficacy of marketed product.
Vendor Management
- Management of translation agency, lab services, logistics, equipment servicing etc.
- We can assist you with infrastructure provisioning of the site quickly and effectively.
- We believe the logistics involved in equipping a site in preparation for the trial can be distracting. Supplying the refrigerators, freezers, centrifuge machines, stationeries, fax machines, cupboards etc. can get overwhelming and confusing when dealing with unfamiliar suppliers and courier companies.
- Our knowledge of local market helps us identify and select the most cost effective suppliers and transport organizations to do the job with minimum of fuss and maximum transparency.
Resource Bank
- Nation-Wide Database Of Clinical Research Professional Viz. Investigators, CRCs, Project Managers, Data Managers
Event Management
- A Training Program Aimed At Providing Foundation To Clinical Research And GCP Guidelines
- Ideal For Clinical Research And Allied Professionals Employed In Pharmaceuticals, CROs, Research/Academic Institutions
- Other Areas:
- Investigators Meet
- B2B Conferences
