Client Challenges

• Stringent infrastructural protocols specified (EDC based trial)
• Patient recruitment only through experienced Investigators
• Looking for speedy IRB/IEC submissions
• Deployment of quality CRC staff with mandatory training

D2L- SMO Achievement Prior to site Initiation

• Selecting Trial sites & PIs for the client
• Setting up the protocol specific infrastructure
• Assisting the sites in PSSV
• Making the Essential Documents for the sites
• IRB/IEC Submissions
• Assisting in getting faster approvals from the IECs
• Assisting in resolving the Queries raised from the Ethics Committees
• Training and Deploying the CRC's at the site

D2L- SMO Achievements After site Initiation

• CRC's at the site helping the PI's in ICF process, Documentation etc
• Achieved the target patient recruitment with in the specified timelines
• Internal pre-monitoring audits from D2L to ensure good quality data
• Continuous GCP Training to our CRC's and the site staff
• Two of our sites successfully audited by the sponsor
• Sponsor approved additional subjects to be recruited in our sites