Dr. Sujay Gowda, MBBS, MD, brings over eleven (11) 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).
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.
Rashmi KJ, MCA, PG, brings over 18 plus years of experience in the Life Sciences & Health Care Industry.
Previously, Rashmi was worked in Philips Healthcare as Sr. Clinical Data Manager and Deputy Manager -Programming for 9 years which was basically on Medical Devices.
Dy. Clinical Database Programming in Reliance Life Science for 5 years.
Executive in Clinical Data Management in Clinigene International, A Biocon Company for 4 years, Software Programmer for 1 year in Biocon.
Sr. Programmer in Milli soft solutions for 1 year.
Clinical Data Management for different Therapeutic Areas.
Design & development CDISC compliant Databases.
Experience in EDC and paper CRF study management.
Systems integration to leverage technology and reduce data redundancy.
Loading External Lab Data Transfer into Database.
By Qualification, Rashmi holds a master’s in computer application, PG in Clinical Research. Honors Diploma in Computer Application.
Clinical Data Management, Design CDISC compliant Databases, Development of CDISC compliant Databases, EDC study management, paper CRF study management, Systems integration, leverage technology, reduce data redundancy, Loading External Lab Data, Lab Data Transfer into Database.
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.
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.
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.