Dr. Pravina Koteshwar is a health care professional, she brings over twenty-two (22+) plus years of rich experience of clinical research and therapeutics.

She started her career as Medical Advisor & HOD of Pharmacology & Toxicology, R&D Centre, Natural Remedies Pvt. Ltd., Bangalore. She was actively involved in planning & product development in accordance to national and international specifications. The key responsibilities included strategic planning, budgeting, execution & supervision of clinical projects related to allergy & immunology, neurology and metabolic disorders.

She contributed to the intensification of clinical research training at Institute of Clinical Research, (India), Bangalore. During her tenure as Assistant Dean & Principal at ICRI, creatively contributed to designing and developing various courses (Master's and Diploma programs) and training modules in clinical research and related fields as per the industry needs and specifications.

As the Course Director, India, for M.Sc. Clinical Research of Cranfield University, UK, she was responsible for consistency and quality education of international standards to be delivered at all campuses of ICRI in India. She has achieved Recognized Teacher Status (RTS) by Cranfield, UK, an eligibility criteria for teaching and guiding postgraduate students.

She established research consultancy services to various organizations including Sponsors and CROs. She has played multiple roles as medical advisor, clinical monitor, project manager, investigator and co- investigator, research guide, etc. in different clinical settings. She has an expertise in critical review and scientific analysis of research dossiers, study protocols and reports.

She is very passionate about ethical aspects of clinical research. She was the Founder and member secretary of ICRI Independent Ethics committee – Bangalore (IIECB). Presently, she is the Member Secretary of Sri Sri Institutional Ethical Committee (SSIEC), Bangalore.

She is heading the department of emergency medical services at Sri Sri College of Ayurvedic Science Hospital & Research Centre, Bangalore. She is a consultant physician in the diabetic management and palliative cancer care. Actively involved in training the undergraduate, postgraduate students and nonclinical staff of hospital on Basic Life Support and emergency medical care. She is trained in Hyperbaric Oxygen Therapy (HBOT).

By qualification Dr Pravina holds MD in clinical pharmacology from Karnataka Institute of Medical Sciences, Hubli, Karnataka in 2002.

Dr Pravina lives at Bangalore and she is contributing to society by organizing and conducting many healthcare activities such as health camps, school health activities, health education and awareness programs for general public, students and employees in different organizations both at urban and rural areas of Bangalore.

Dr. Sujay Gowda, MBBS, MD, brings over fifteen (15) plus years of experience. He is a medical professional also experienced in Strategic Management, Clinical trial operations, Business Development, Project Management and Resource Management.

Previously Dr. Sujay worked as a Medical Lead, Clinical research at Sami-Sabinsa Group Limited, for 3 plus years.

Resident medical doctor at Safdarjung hospital, New Delhi, AIIMS- New Delhi and Medanta Hospital, Gurugram for 3 years.

Tutor at Odessa State Medical University, Ukraine in the department of pathology and medicine.

Skilled in review and approval of key study documents, such as protocol, investigator brochure, Informed consent form and other study related essential documents.

Excellent in supervising and coordinating all the medical issues related to ongoing clinical projects, along with supervising the safety issues throughout the clinical study.

Overseeing of medical and scientific quality of clinical trial protocols.

Proficient in preparing and reviewing of Investigational Product Dossier.

Resolving the project operational issues with seasoned medical opinion during the conduct of the trial.

Instrumental in ensuring complete compliance with all federal, state, and local guidelines dictating clinical trial standard practice.

Successfully published 4 research papers in eminent journals, excluding 2 which are still under review.

By Qualification Dr. Sujay holds degree in Doctor of Medicine (General Medicine).

CORE COMPETENCIES

Clinical Research, Medical writing, Monitoring and Audit, Adverse event Management and Safety reporting, Project Management, Relationship Management, Resource Management, Project Deliverable, Strategic Planning, Business Development.

Consultant Director at Syncorp Health. He comes with a service industry experience of over 22+ years. Exposed to business operations, strategic management consulting, strategy alignment and implementation within life science domain. Hands on experience in business vertical building and executing growth strategy of the organization and functions like Biostatistics, Statistical programming, Data Management & Electronic Submissions.

His recent past assignment includes P&L responsibility for multiple customer accounts, having worked on global hybrid businesses on account management. Setting up operational metrics to proactively eliminate issues, cost minimization initiatives, build YOY efficiency in operations to grow revenue and savings. Responsible to identify key growth areas & devise offshore strategies.

Experienced in crafting domain specific life science outsourcing solutions and business models to address business demands & help clients to utilize global delivery models.

He has been an active participant and core member of the PhUSE working committee, in the past 3 years he has hosted 2 single day events (SDE) at Bangalore and an active contributor on other professional arena. His next event is scheduled (work in progress) for a pre-conference workshop at Mumbai.

He is trained and certified in Statistical Quality Control from Indian Statistical Institute. Quality professional with keen interest in Quality Initiatives and Six Sigma Black belt trained.

By Qualification he is a post graduate in management (Majors: Lean Operations) from Alliance Business School, Bachelors in Engineering and Computer Science from National Institute of Engineering, Mysore University.

Dr. Smitha, MSc., PhD, brings over 12 plus years of experience in the Statistics, Life Sciences & Health Care Industry.

Previously, Dr. Smitha has worked in Novo Nordisk Service Ltd as Statistician for 3 years.

As Data Analyst in GE Capital.

As Guest teaching staff (for MSc. Statistics) at Mangalore University.

As Consulting Statistician & Teaching, Research Assistant (For non-statistician researchers) in Department of molecular biology and genetics at Aarhus University, Vjele, Denmark.

As Lecturer in statistics at MGM college.

Statistical Inputs for Protocol on methods, sample size.

Preparing and reviewing Statistical Analysis plan.

Efficacy analysis / Validation programs and statistical output reviews.

Team lead for all statistical and programming activities.

Support and guide the team in the development, maintenance of data management macros for output generation that optimize the efficiency of statistical analyses and reporting.

By Qualification, Dr. Smitha holds a PhD in Applied Statistics from Denmark, Master’s in Statistics from Mangalore University and Bachelor’s in Mathematics, Statistics and Physics from MGM College.

CORE COMPETENCIES

Statistical part of the protocol, Sample size calculation the clinical trial, Blinding and breaking of the blind, Statistical Analysis Plan, Statistical report writing, Statistical Inputs for Protocol on methods, sample size, Randomization.

Dr. Satish, MTech., MSc., PhD, brings over 12 plus years of experience in the Medical writing, Clinical Research, Life Sciences & Health Care Industry.

Previously, Dr. Satish has worked in Trial Guna as Medical Writer, Data Services

As Assistant Professor (Pathology, Physiology & Anatomy) in REVA University

As Clinical Research Associate II at Consortium Clinical Research Pvt Ltd for 4 years.

As Clinical Research Coordinator at Lotus Clinical Research Pvt. Ltd for 2 years

As Medical Executive at Mayer Organics Pvt Ltd for 4 years

Authoring clinical documents that are part of regulatory submission including Protocol, Investi-gator Brochure (IB), Informed consent document (ICD), Clinical Study Report (CSR) across the various Therapeutic areas.

Documents must be in line with ICH-GCP E3, E6 guidelines, Company SOPs

Responsible for the planning, writing, editing, reviewing, and coordinating the publication of clinical data to peer-reviewed journals.

Data Quality checking of the clinical documents

Responsible to produce abstracts, short communications, manuscripts, review articles, global medical slide sets, study slide sets, manuscript slide sets (PDF, MS-PowerPoint & Word), slide sets for posters, slide set for oral presentations at scientific congresses, and other written commu-nication material supporting pharmaceutical brands, research activities, and business needs.

Acts as a subject matter expert in medical writing

By Qualification, Dr. Satish from University of Mysore holds a PhD & Master’s in Biochemistry, MTech in Environmental Sciences and Technology and Bachelor’s in Botany Biochemistry Zoology.

CORE COMPETENCIES

Authoring clinical documents, Protocol, Investigator Brochure (IB), Informed consent document (ICD), Clinical Study Report (CSR), ICH-GCP E3, E6 guidelines, planning, writing, editing, reviewing, and coordinating the publication of clinical data to peer-reviewed journals, manuscripts, review articles, global medical slide sets, study slide sets, manuscript slide sets.