Dr. Harisha. S, Managing Director
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.
Chirag Khatri - Director-Operations
A Pragmatic leader credited with aggressively growing Businesses through vision, building global winning teams and driving execution towards project management, quality assurance, Bioanalytical or clinical operations & business development for Pharmaceutical industry segment
He is a Post graduate in Chemistry from University School of Science-Gujarat with a total of 19 years diversified experience in the field of Bioanalytical, Analytical, Quality Assurance & Clinical Research. His association has been with the research centers of major pharmaceutical companies like Cadila Pharmaceuticals Limited-Dholka and Sun Pharma Advanced Research Centre-Baroda. Lastly he was employed with RA Chem Pharma Pvt.Ltd – CRBio, Hyderabad- a Clinical Research CRO.
He has expertise in
- Establishing Quality system in Clinical Research facility for conducting bioavailability / bioequivalence studies.
- Analytical / Bioanalytical method development and validation as per regulatory guidelines
- Preparation and review of SOPs, Validation reports and Qualification documents
- Establishing clinical sites for conduct of BA/BE studies on patients
Has vast experience in conduct of more than 300 bioequivalence studies
Ms. Lalitha V Kamath - Senior Manager – QA
Having two decades of experience in Pharmaceutical industry including manufacturing and various CRO’s, she is well versed with GMP, GLP and GCP regulations. She is a gold medalist in Masters Degree in Chemistry from Kuvempu University besides holding Post Graduate Diploma in Clinical Research and Regulatory Affairs from Sikkim Manipal University. Awarded certificate as a technical staff for chemical and instrumentation by Govt. of Karnataka Drugs control department, she is having sound knowledge and experience in handling and trouble shooting of instruments like HPLC, GC, IR. She is experienced in handling regulatory audits like DCGI, USFDA, WHO and EMEA in various CRO audits. Certified as Internal auditor for ISO 9001: 2008, ISMS 2700: 2013 & ISO 15189:2012 by ISO certification body, has sound knowledge in implementing these standards in the organization.