Er. Vinod Kalra is an Engineer by Professional training, an Excellent Administrator with more than 4 decades of the experience in Defense services. Heads Administrative and Financial domain. Facilitates the Business development for effective and efficient service delivery with support of Experts and Consultants on board.

Dr. Monika Bahl is a medical professional with strong academic background, trained in human resource management, project planning and management with over 25 years’ experience in clinical research industry/ organizations. Significant experience of managing projects in varied therapeutic indications. Research experience spans over broad spectrum of responsibilities from clinical development program, grant writing, project planning, protocol designing, regulatory, operational & medical monitoring, data review and medical writing and overall project management for clinical trials, academic projects and research initiatives of national interest. Involved in training, managing mentoring and performance improvement of the team and quality management initiatives on individual, project and organization level.

Assignment with Pharmaceutical companies has been a value addition in terms of strategic planning and operational execution of research activities and clinical trial management, resource utilization and forecast resource requirement to facilitate effective resource planning throughout the life of the product development, define project workloads and assignment and develop and oversee maintenance of internal databases and project plans.

As Director- Clinical Portfolio Management with Clinical Development Services Agency an extramural centre of THSTI (DBT, Govt. of India) has been leading the public health research portfolio in collaboration. with DBT, ICMR, academicians, SMEs, researchers and funding agencies, responsible for development of overall strategy, contribute to developing the clinical trials/studies portfolio including grant /medical writing, clinical operations and safety monitoring. Active involvement and support to experts / KOLS for the revision of GCP guidelines.

She is Founder Director of ‘Shodh Clinicals Solutions’. She is working asconsultant and leading the clinical research programs and medical oversight for collaborative projects and engaged as senior advisor with CROs and Pharma companies. She works as technical experts with Inclen International, DNDi, \ICMR, BIRAC, SMEs, CROs and academic institutes. Technical advisory member for GCP Personal certification Scheme, IEC Chair /Member and a visiting faculty to research organizations and leading academic institutes. Good understanding of the regulatory and operational processes/guidelines that govern the clinical research industry, working in collaboration with experts (industry, academicians, SMEs, public health professionals).

About Shodh Clinicals

'Shodh Clinicals' a clinical research organization working towards achieving 3-D approach, ‘Deep Dive to Deliver Quality’ for Quality in research programs and initiatives. We aim to support and work closely with the academicians, SMEs, research institutes and scientists in public health domain to support them on research programs as per requirements (Grant and protocol designing, Project planning and management, Medical monitoring, Quality Management, Audits) and also undertaking training programs.

A Clinical Data Management professional, Ms. Archana Bhattacharya is a certified ITIL and six sigma green belt from the National Institute of Statistics.

She holds a cumulative experience of 26 years with 22+ years of work experience in Data Management, and 17+ years in Project Management.

Pharma professional with 20+ years of experience, Dr. Batolar has partaken in the registration of new drugs and life cycle management for India, Sri Lanka, Bangladesh, Nepal, Maldives, and Bhutan, along with clinical development of NCEs, Biosimilars, Generics, and BA/BE studies.

Well versed with regulations of US-FDA, EMA, MHRA; ICH-QSEM, Indian GCP, Schedule Y, CONSORT

Meenakshi is a competent strategic and operational Quality Management professional with over 23 years of experience in design, implementation and maintenance of Quality Management Systems (QMS) in domains of tertiary hospital-based laboratories, central reference laboratories and Clinical Research in both domestic and global clinical operations settings. She is a postgraduate in Biochemistry and certificate courses in Clinical Research. She currently is Director- Quality and Projects at DrDangs Lab laboratory. Her role at the lab involves promoting quality culture and to continuously enhance QMS to meet and exceed accreditation and regulatory requirements. She actively supports newer initiatives and projects of the organization. Additionally, she educates and drives quality culture for clinical laboratory and clinical research programs to support GCLP, GCP, and other GxP work in planned trials (vaccines and therapeutics) including clinical & immunogenicity laboratories. She is trained on ISO 15189 and ISO 13485 certifications.

In her previous assignments, she has successfully handled responsibilities of increasing complexities, including leadership positions, in Corporate QA and possesses sound knowledge, understanding & experience in applying global GCP/GCLP standards and regulations.

Mr. SurajMadhavan has more than 17 years’ experience in the pharmaceutical industry encompassing all phase of clinical trials in Asia-Pacific and European countries across multiple therapy areas. Having worked in both contract research organizations, as well as small and large pharmaceutical companies Suraj has extensive experience on key operational aspects of drug development. Suraj was responsible for oversight of large-scale global programs in the areas of oncology, gastroenterology and psychiatry. Suraj has led projects that went on to successfully obtain US FDA and EMA approval.

He has a proven track record of managing the studies successfully with the specified timelines and budgets. Currently he is associated with Innvocept Global Solutions as its Co-founder and Director, Clinical Operations and Project Management. Suraj holds a Master’s degree in pharmacy from Manipal Academy of Higher Education.

Dr. PratibhaPerriera(MD, General medicine), Professor and HOD, Geriatrics Department of JSS Medical College (JSS AHER), Mentor and Head of the research centre and Institutional Ethics committee member and Head Dept of quality with vast experience in clinical research initiatives. Her areas of specialization and experience are geriatrics, clinical research and Standards of Quality for hospital. She has set-up and operationalized the Geriatric Units in KMC Mangalore and has become a part of national colloquium on elderly care. She has worked as NABH assessor and has been Technical committee member of the Ethics Committee Accreditation for NABH and a part of ICMR sub-committee for the revision of guidelines, instrumental in developing NABH EC standards of accreditation. Trained all PHC doctors and nurses and developed manual for NCD cell.

She worked in Department of geriatrics in JSS Medical college (JSS AHER) and started the Research center at JSSAHER. She is involved in many other activities like talks on health care in elderly and active aging at various forums, and Udaya T.V Live and MysuruAkashwani and various forums. She has been part of many research like Ginkocer Trial in Elderly, Hypertension Survey in Elderly, Bone Disorders Survey in Elderly, Drug Compliance in the Elderly, Assessment of creatinine clearance 6 by UV/P in the Elderly, Comparison of Pneumococcal Vaccine with 3 weekly injections of 1.2 million Units of Benzathine Penicillin in Pneumococcal infections Postgraduate Research, Nutritional assessment in elderly with intervention and Zinc deficiency in elderly with intervention.

She involved in public education of elderly issues and training of aspiring researches on ethics in biomedical research and GCP. Due to her work passion, hard work, knowledge and experience, she was awarded by many awards as Distinguished alumni award, Young scientist award by API, Double Helical award for services in geriatrics, Recognition for work done in Quality by NABH and Recognition award for sensitizing on GCP. She is life member of GSI and IGS, API, RSSDI, ISCR and FERCI.