Case Studies
Case Study 1 – Percutaneous Coronary Intervention
Client: Large Global Medical Device Company
Study Phase: Post Marketing Surveillance
Study Device: Drug-Eluting Stent
Services Offered: Project Management and Clinical Monitoring
Highlights:
- One of the Largest Global Drug Eluting Stent Study
- Multi-centric post marketing study with long term follow up design (05 years)
- 540 Patients recruited from 05 sites in India within the timeframe with
an average rate of 108 patients per site as against average of 40 patients globally - Excellent Patient Recruitment rate (15% of global enrolment was done across 5 sites in India)
- Maintained >95% follow-up Compliance at 3 years of study follow-up
Case Study 2 – Bradyarrhythmias
Client: Large Global Medical Device Company
Study Phase: Post Marketing
Study Device: Permanent Pacemaker Implantation
Services Offered: Project Management and Clinical Monitoring
Highlights:
- Global Pacemaker Registry for Bradyarrhythmias
- More than 1500 Patients globally
- Study Follow-up 02 Years
- More than 50 Sites across the Globe and 04 Sites in India
- Quick execution of Clinical Project across India
- Contract Signed in Jan 2011, Ethics Committee Approval obtained in Feb 2011 and FPFV conducted in Mar 2011
Case Study 3 – Acute Coronary Syndrome
Client: Renowned Indian Multinational Pharmaceutical Company
Study Phase: Post Marketing Surveillance
Study Drug: Anti-thrombotic Drug
Services Offered: Project Management, Clinical Monitoring, Data Management and Medical Writing
Highlights:
Multi-centric, Post Marketing Surveillance Study of Anti-thrombotic Drug
- Moderate to High Risk ACS patients undergoing PCI were enrolled
- Enrolment of 441 patients from 11 interventional sites in India
- Targeted enrolment completed ahead of schedule at the rate of approximately 60 patients/ month
- Medical Writing of manuscript accepted in renowned journal of Cardiology