The global pharmaceuticals market is growing constantly to align with the worldwide increase in life expectancy and the increasing incidence of chronic and infectious diseases. Also, the global pharmaceutical giants are outsourcing R&D to emerging economies like India to take advantage of the scientific work pool and lower costs. Jeevan Scientific Technology Limited as an independent full-service CRO is offering end-to-end BA/BE, Pharmacovigilance (PV), and Clinical Trials (CT) services and has made a good mark in the global platform with a huge client base. Incorporated in 1999, the company offers various services including IT, Medical Writing, and forayed into Clinical Research in 2014. It provides an integrated solution for the management of clinical data right from its inception to completion.
Jeevan as a leading CRO has supported many customers in carrying out their BA/BE studies at Jeevan, post which they have received Marketing Authorization for those products. "Selection of the right CRO is vital for a successful market launch of your product," says Snigdha Mothukuri, CEO and Executive Director, Jeevan Scientific Technology Ltd.
Jeevan stands out for its adherence to high-quality standards and has been focusing on continuously improving it with a well-defined Quality Management System (QMS) complying with all regulatory standards. Being armed with a world-class team of highly qualified and experienced workforce enables Jeevan to meet the client expectations and deliver within the timeframe.
“We adopt a transparent approach in understanding the expectations and conveying the plausible deliverables, upcoming challenges along with the necessary assumptions. We have completed around ten audits including CDSCO, US FDA, and WHO so far and more than 60 multiple sponsor audits and have successfully executed more than four hundred and fifty studies,” says Snigdha.
Jeevan has a dedicated and experienced Project management team to ensure the client needs are conveyed seamlessly to the operations team and vice-versa. It adds a personal touch to each of its clients by understanding their business goals and values along with their regulatory needs. Jeevan maintains a comprehensive database for each of its clients and continuously updates the internal standard operating procedures as per the changing requirements maintaining a long-term relationship with them. “As a service-oriented company, our capabilities are broad and we are open to handle case processing of all types of cases,” adds Snigdha.
Jeevan can handle risk management plans, risk evaluation mitigation strategies, signal detection assessment, PSUR, PBRER, PADER, and many other services as per the client's requirement. The facility has a state-of-art equipped medical information contact center which is being monitored 24/7 by well-trained and dedicated staff. The services include outbound, inbound calling, handling of medical information, adverse events, and product quality complaints. Jeevan manages studies across various therapeutic areas, drug delivery systems, and geographies.
As a cro, our capabilities are broad and we can ramp up to accommodate higher case volume
Jeevan has already executed large molecule complex generics studies like glucose clamping studies and has also ventured into biologics clinical trials. Recently Jeevan’s clinical pathology lab has been assessed and received NABL accreditation in March 2021. “Now we are successfully carrying out most of the diagnostic tests in-house. We are also trying to add value to the health care industry by executing a few of the major clinical trials in India to bring out new cheaper drugs in demanding therapeutic areas like Oncology,” confirms Snigdha.
In addition to monitoring its financial targets, Jeevan also checks its utilization and quality targets continuously along with improvising the necessary internal controls for better visibility, efficiency, and planning. The company aims for doubling its revenues through an organic growth plan in the coming three years by reaching out to new markets with a focus on specialty areas in BA/BE and aggressively growing in asset-light businesses like PV and CT. “We are mainly focusing on innovation and building our internal capabilities through expansion of teams with the addition of new talent and also by increasing our efficiencies,” concludes Snigdha.