Pharma Edge Centre overview

Pharma Edge www.pharmaedgecentre.com Pharma Edge Centre ( I ) Pvt. Ltd An OverviewPharma Edge www.pharmaedgecentre.com Pharma Edge Centre ( I ) Pvt. Ltd. A Hyderabad based company Main objective is to provide various services in clinical trials ( including BA/BE studies) fieldPharma Edge www.pharmaedgecentre.com Training (visit the website for all topics) • GCP & GLP training ( for individual CROs) • Workshops on various topics • WinNonlin and SAS training ( individual & group) • Training on setting up BA/BE facility • Phase I clinical trial Audits • CRO audits (Suitability to conduct studies) • Study audits ( in process & retrospective) • External QA audits • Final Report audit (prior to submission) ServicesPharma Edge www.pharmaedgecentre.com Services Clinical trials • On site services to sponsors • Phlebotomy services • Data management • Site coordination • Study monitoring for sponsor PK & Statistical analysis • WinNonlin and SAS analysis of BA/BE study data • SAS analysis of clinical trial data • Report preparation Pharmacovigilance • Full service from initiation to reportPharma Edge www.pharmaedgecentre.com Recent Workshops 1. Preclinical research and Phase I studies 24 & 25 Jan 2009 at YMCA, Panjim, GOA 40 participants 2. Basic Principles of LC/MS/MS, advances in Bioanalytical method development and regulatory requirements in Bioanalysis 25 & 26 April, 2009 at Tunga Paradise, Mumbai 45 participantsPharma Edge www.pharmaedgecentre.com Manpower Qualified and trained manpower based at • Hyderabad • Mumbai • Bangalore Resource personnel for workshops • Selected from different CROs and pharmaceutical companiesPharma Edge www.pharmaedgecentre.com Present activities 1. Providing consultancy services to R&D Centre of leading Pharmaceutical company in Mumbai 2. Providing study monitoring & phlebotomy services at one of the clinical trial centres at Hyderabad for a pharma company from Mumbai 3. Completed GCP & GLP audit of a CRO to ensure suitability for conducting US FDA studiesPharma Edge www.pharmaedgecentre.com Thank You! I ts Time for…….