Dr. Milan C. Satia

Founder & Managing Director

The clinical trial market in India has seen significant growth over the past few years. It is considered one of the key hubs for clinical research globally. Sever­al factors have contributed to this growth including cost advantage, large and diverse patient population, positive regulatory reforms, increasing focus on R&D, improving infrastructure and technology, and availability of skilled workforce, which allows for research studies across a wide range of demographics and medical conditions. That said, there are plethora of obstacles the industry is fac­ing such as ethical concerns, data privacy issues, and the need for better quality control and regulatory oversight.

Acknowledging these challenges and understanding the market’s true potential, Ethicare Clinical Trial Services is one pioneering business organization that aspires to be a trail-blazer in the Indian clinical trial market. Owing to its commitment for consistent improvement, Ethicare as of now has positioned itself as a leading and reputable clin­ical trial organization in the Global market. It is also rec­ognized as a trusted partner for pharmaceutical, biotech, nutraceutical, and medical device companies across the globe seeking to conduct clinical trials as well as providing pharmacovigilance services based in India.

Offering Comprehensive Solutions

Ethicare emphasizes on expertise, experience, compliance, diversity of the patient population, timely and efficient delivery, and collaborative approach. This has helped the company to expand its horizons and position itself as a reliable, quality-driven, and cost-effective player in the industry. When asked about the flagship services offered by the firm, Dr. Milan C. Satia, Founder and Managing Director, Ethicare states, “We offer end-to-end clinical trial management or any part thereof. It includes medical writing, study start-up & feasibility, site and investigator selection, regulatory document preparation and submission, project management & coordination, monitoring, closeout activities and complete data management through electronic data capture.

Other than that, we also provide end-to-end pharmacovigilance (PV) services which include - Safety PV in Clinical Trials – Safety Management Plan, Development Safety Update Report, Data Safety Monitoring Board, and Post Marketing Pharmacovigilance – Individual Case Safety Report, Aggregate Reports (PSUR/PADER/PBRER/ASR/RMP), Signal Management, PV System Master File, QPPV/LRPV for Europe, Product Label Management, Global Literature Management, Risk Minimization Measures, Clinical/ Non-Clinical Modules, and 24x7 Medical Information Management System”.

Ethicare strives to provide comprehensive support to its clients throughout the entire engagement cycle starting from scheduling an initial signoff of the confidentiality agreement to understanding client requirements and objectives, which leads to desired outcomes and budget proposal which includes a detailed budget breakdown, recommended approach, timelines, and services tailored to the client's requirements, assembling a dedicated project team comprising of experienced professionals with expertise in the specific therapeutic area, and helping them to submit and get approval from the regulatory agency after completion. Aside from this, the company also provide post-study support, including assistance with the publication of study results, and addressing any queries or requests from regulatory agencies.

Catalyst of positive change

Ethicare has assembled a team of experts from different domains to offer the best services to its clients and adding more about its team, Dr. Milan C. Satia says, “Ethicare has a team of 75 plus people, having a combined 350 years of cumulative experience. The technical team largely consists of medical doctors, Ph.D. in Pharmaceuticals, Pharm.D. and M.Pharm. Our individual department heads are having 12 years to 20 years of experience. Our team comprises of highly skilled professionals with extensive expertise in various aspects like Clinical Operations, Pharmacovigilance Operations, Medical Writing, Data Management, Quality Assurance, IT and HR management”.

There are plethora of factors which helps Ethicare to stand out from the rest of its competitors including customized solutions, leveraging expertise in identifying the gaps, use of current technology and innovation, robust quality assurance, and dedicated customer support through effective project management. Ethicare follows a comprehensive approach to ensure the best return on investment (ROI) and the company has impressive client retention ratio with many of its clients working with it for more than 10 years. The meticulous effort put in by the company has also helped it to scale for greater heights in the market and building business development people in the US, EU, and UK aside from India.

Ethicare was established with a mission to shape the future of the clinical research industry by ensuring quality, reliability, the scientific validity of all clinical projects, and complying with global regulations. Over the years, the company’s projects have been accepted by UK, MHRA, EU and US FDA apart from CIS and Latin American countries. Till date the company has completed more than 100 clinical trial projects covering 12000 patients’ recruitment at 400 various hospital sites in India, South Africa and Nigeria. Also, in the last three years, the company has cleared six US FDA, two Kazakhstan & one Health Canada inspection for PV services without any major observation.

Evolving with the changing times, Ethicare aspires to continues its focus on growth, innovation, technology upgradation and maintaining its position as a trusted CRO partner. The company aims to constantly expand its capabilities to deliver unparallel value to its clients and help them bring life-changing therapies to patients worldwide. By partnering with Ethicare CRO, pharmaceutical and biotech companies can tap into their resources, knowledge, and experience. This collaboration empowers companies to navigate the intricacies of clinical development, regulatory compliance, and post-approval activities with greater efficiency and effectiveness.