Since our inception in 2011, we have toiled to persistently take steps to improving our extent of expertise and scientific acumen. This has enabled us to assist in providing solutions to both simple and highly complex clinical trials across several therapeutic areas. We have provided both operational and consultancy services at early clinical development phases for pharmaceutical and biotech drug companies.

These experts are core of the company, promoting our visionary prospective thinking and team based learning culture. An utmost importance is given to scientific innovation, meticulous attention to details and dynamic quality improvement with high priority approach to safety and outcomes with time in control.

Our innovative, rationale and out of the box thinking coupled with scientific temperament can make a significant difference to the outcome of the clinical development programs for our esteemed clients.

Ramesh Makkena, MS

Founder and Managing member

Mr. Makkena has significantly contributed to nurture the vision and mission of CRC Pharma. He has been instrumental in driving CRC Pharma’s decision-making processes and building a talented pool of experts, scientists and clinical professionals. Prior to starting this company Mr. Makkena has worked at small and large Pharma and Biotech companies for over 14 years. His expertise has been in clinical reporting of all phases of clinical studies, across a wide therapeutic areas. Mr. Makkena has high technical knowledge of the SAS language, HL7, ICH, CDISC SDTM, ADaM standards and clinical trials disclosure. He has provided programming expertise to 6 NME’s, including reporting of Phase I-IV individual trials, pooled analysis, exploratory analyses, and responses to regulatory authority queries.

Mr. Makkena received his BS in Mathematics and MS in Computer Applications from Nagarjuna University, India.

Ramesh Makkena, MS

Founder and Managing member

Priyanka B. Ingle-Jadhav, Ph.D

Translational Clinical Pharmacologist

With over 10 years of translational research experience involving clinical and laboratory studies, Dr. Ingle-Jadhav leads scientific innovation at CRC Pharma LLC. Her role is prudent in representing and implementing company’s strategic vision and pioneering innovation by devising complementary alliances. As a Clinical-Regulatory expert Dr. Ingle-Jadhav consults for early stage transition of molecules and devices, and supports during their regulatory pathways. Dr. Ingle-Jadhav is involved in devising and implementing of CRC Pharma’s perspective for Business and Clinical Regulatory Services. Her role is crucial in integration of subject matter expertise for generating novel product concepts, supporting drug development programs, liaising with partners and commercialization of technologies. Dr. Ingle-Jadhav is a Physician-Researcher specializing in Pharmaceutical Medicine, Clinical Pharmacology. One of the major areas of her research focuses on Complementary and Integrative Health Medicine involving both lab and clinical methods. She brings in expertise of diverse therapeutic areas like infectious diseases, immunology-autoimmune diseases, pathology, dermatology, diabetes and domains like Outcome research focusing on HRQOL studies.

Dr. Ingle-Jadhav, received her medical degree and PhD in Pharmaceutical Medicine from State Health University, Mumbai, India and postdoctoral training at UF diabetes institute, University of Florida, Gainesville, Florida. She has published several peer reviewed research articles in reputed research journals, co-edited a book, authored chapters in books, presented at national and international conferences, won many awards and also contribute as associate editor to the Journal of Ayurveda and Integrative Medicine.

Priyanka B. Ingle-Jadhav, Ph.D

Translational Clinical Pharmacologist

Manoj P. Jadhav, PhD, FCP

Translational Clinical Pharmacologist

Dr. Jadhav is responsible for strategic, scientific planning and business functions for the organization. He also act as a consultant to the clinical development plans for the clients, involved in regulatory and medical writing etc.

Dr. Jadhav brings in his experience of over 10 years in industry and academia. He is a trained clinical pharmacologist with extensive experience in planning, designing, execution and interpretation of clinical studies (prospective, retrospective, interventional and observational) in the area of, cancer, cardiovascular and infectious diseases. He was part of successful team which developed first Indian liposomal amphotericin B (Fungisome TM) and launched in Indian market. Dr. Jadhav has over twenty-five peer-reviewed publications, co-edited a book, have made numerous posters and oral presentations internationally.

Dr. Jadhav received his PhD in Pharmaceutics from Bombay College of Pharmacy and KEM Hospital, University of Mumbai, India and did his Post-Doctoral fellowship at the Colleges of Pharmacy and Medicine Univ. of Florida, Gainesville, Florida.

Manoj P. Jadhav, PhD, FCP

Translational Clinical Pharmacologist

Siva Kumar, M.S

Operations Manager

Mr. Siva Kumar oversees all the operations related aspects at CRC Pharma. He has over 18 years of extensive work experience in Healthcare and IT industry. He has a track record of managing multiple projects/programs/customers and globally diverse onsite / offshore team members, technical experts.

He has adriotically handled various teams, their performances, provided technical expertise and mentored many young professionals. He has a sharp acumen for business development, maintaining client relations etc. Mr. Kumar has exceptional experience in statistics and reports on account performance, IT governance, QC, checks and has high level technical expertise for trouble shooting in these domains. Worked as senior project manager and handled highly complex technical and financial situations.

Mr. Kumar received his Masters in Computer Applications from Osmania University, Hyderabad, India.

Siva Kumar, M.S

Operations Manager

William Stewart, Ph.D.

Founder-Advisor

Dr. Stewart has over 30 years of clinical trials experience in Phases I-IV as a Biostatistician, Biostatistical Group Head, Biostatistical Quality Group Head, and Statistical Programming Group Head.

Dr. Stewart received his Ph.D. in Research Design and Statistics from City University of New York, and also holds a MS in Statistics from Florida State University and a MS in Genetics.

William Stewart, Ph.D.

Founder-Advisor