Dr. Harish.S, CEO
Dr. Harisha With his entrepreneurial and organizational skills he has been able to grow ICBio to become one of the premier CROs in the country. As a Board member he gives strategic and financial direction to Company.
Dr. Harisha also Head–Clinical Development and BD team, wherein he upheld the responsibilities of managing the Clinical Trial Department while conducting Phase II-IV Clinical trials. He has rich experience and expertise in ensuring Compliance with the applicable Global Regulatory standards and ICH-GCP in all the Clinical Development he managed. He believes that if done in an ethical manner, clinical research is a very attractive socio economic opportunity for India. By qualification, he is an M,Sc, Ph.D, in Biochemistry, with 16 years of work experience which includes 8 years of Industrial Clinical Research experience preceded by 8 years of Research and Teaching, his experiences in coordination of all phases of global and domestic clinical trial activity in India. His experience includes designing and reviewing clinical trial related SOPs, designing SOPs for Ethics Committees, budgeting for Clinical Development. He also has the credit of publishing four books & edited seven books, 74 research publications.
He has long-standing professional relationships with individuals, institutions and corporate working in the domain of CRO, SMO, & Biotechnology across the world. He has led large clinical operations teams and brought many innovations to the field including strategies, systems and processes for faster enrollment and increased retention.
He was worked as Director - Academics, ICBio Training wing, developed a global training program and has personally trained hundreds of pharma, CRO, SMO and Site employees in ICH-GCP.
Ms. Pushpa Latha G, Director
Mrs. Pushpa Latha G has been awarded Bachelor degree in Engineering from Visvesvaraya Technological University; she has been in the IT industry and has rich experience in software development, analysis, design, implementation and training. She is instrumental in implementing quality procedures in projects. She worked as Software developer in Hewlett-Packard (HP) and has worked in companies like Satyam and NIIT Technology. She is presently handling business development, resource planning.
- Quality Assurance
- Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.
- Clinical Development
- Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.
- Bio Analytical
- ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.
- Project Management
- ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.
- Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.