Mr. Niraj Shethji has more than 17 years of research experience working at CROs and Pharmaceutical companies, supporting the early and late phase clinical trials. Before joining Novum, Mr. Shethji served at Sun Pharmaceuticals, Pharma Medica Research, Biovail Corp. and Watson Pharmaceuticals (currently Teva) in variety of roles and increasing responsibilities. He joined Novum in Yr. 2011 to provide scientific leadership to the talented team of scientists, technical writers, statisticians and programmers. In addition to his broad experience with the conventional oral dosage forms (solid/liquid), he gained wide-spread exposure to the design and conduct of the biostudies for complex dosage forms such as transdermal, topical (including corticosteroids), injectable, nasal/inhalation, vaginal/rectal products.
Mr. Shethji has hands on experience in developing study designs and protocols for the NDA/ANDA/505b2 submissions, statistical evaluation/presentation of data and generating high-quality study reports. Mr. Shethji’s diverse experience in fields of PK, PD, bioanalysis, biostatistics, efficacy trials and regulatory sciences assists in directing Novum team in day-to-day functions and guiding clients in their development/submission strategies. He has been greatly involved with Novum’s project management in providing the scientific and operational support to meet client’s expectations. Mr. Shethji received Masters of Pharmacy (Pharmacology) in Yr. 2002 and BS in Pharmacy from University of Pune in Yr. 2000.
Dr. Solanki is a medical professional holding post-graduate degree in Pharmacology from Gujarat University, India. Dr. Solanki has demonstrated expertise in advisory role across diversified functions like Clinical Research, Regulatory Affairs and Medical Services over a span of 14 years. Prior to joining Lambda, Dr. Solanki was associated with Intas Pharmaceuticals Ltd, India and Ranbaxy Laboratories Ltd, India as Medical Advisor. In the past, he has also worked as Associate Professor, Institute of Clinical Research, India in collaboration with Cranfield University, Bedford, UK. Dr. Solanki is certified for “Understanding FDA and the FDA Approval Process” by FDASmart Inc, USA. Dr. Solanki is currently guiding teams & clients on ushering applied pharmacology concepts for adequate scientific inputs towards new drug development proposals with innovative concepts for global introduction towards furthering Pharmaceutical Intelligence activities.
Mr. Ronak is leading the global Clinical Data Management and Biostatistics division at Lambda Therapeutic Research. He is having around 20 years of experience in Clinical Trial Data Management and Biostatistics services. He has extensive exposure in managing clinical data management efforts for Phase 1 to 4 studies with implementation of global standards in Clinical Data Management systems. Mr. Ronak is focused in optimizing data management and statistical processes through improved project management, data standards and innovative solutions which results into high-quality data and efficient timelines to database lock. Presently, the data management group at Lambda is actively involved in implementation of eCRF projects across the global subsidiaries of Lambda. In his leading role, Mr. Ronak trains young biostatistician & programmers and supports them to understand the requirements of the clinical research and regulations. With his statistical expertise, Mr. Ronak has contributed 12+ research publications in various journals. Under his leadership, CDM and Biostatistics team at Lambda is committed to produce results that are accurate, accessible and reproducible.