Our Business
Our Company was incorporated as Clinsearch Labs Private Limited on April 23, 2004 We are an independent, global full-service contract research organization (“CRO”) offering a comprehensive portfolio of services across various stages of the drug development value chain ranging from non-clinical and preclinical development and testing to early phase clinical pharmacology, bioavailability and bioequivalence studies and early to late phase clinical trials for different modalities of drugs including novel chemical entities, novel biological entities, generics and biosimilars besides medical devices.
Our services include :-
- Early phase and late phase clinical trials (“Clinical Trials”).
- Healthy Volunteer studies (“HVS”) which includes bioavailability studies and bioequivalence studies.
- Pre-clinical trials and non-clinical testing (“Pre-Clinical”).
- (iv) biopharma services which includes non-clinical analysis and clinical bioanalysis of large molecules (“Biopharma Services”).
We are present across the key global markets including North America, Europe and Asia, including India.
we commenced our operations with our first facility in Ahmedabad, Gujarat with HVS capabilities, which was set up in 2005.
Brief details of the services being offered by us are set forth below :-
Clinical Trials :- Clinical Trials comprise early to late phase clinical development studies (Phase I, II, III and IV Clinical Trials) conducted in patient populations across multiple hospital sites.
Phase I Clinical Trials typically involve safety and clinical pharmacology studies of pharmaceutical products in patient populations covering aspects such as safety, dose range, food and gender effect and such similar clinical pharmacology studies, that determine whether further clinical trials can be planned.
Late phase Clinical Trials (Phase II and Phase III) typically study the safety and efficacy of pharmaceutical products in larger and diverse populations which is then used by regulatory agencies for granting market authorization for these products.
Phase IV Clinical Trials typically collect safety and performance data of pharmaceutical products post marketing across diverse patient populations We provide the scientific, operational and regulatory expertise to conduct these trials across diverse geographies, hospital sites and populations.
Healthy Volunteer Studies (“HVS”) :- HVS comprise conducting clinical pharmacology studies in healthy volunteers in our clinical facilities, and essentially generating data on pharmacokinetics and pharmacodynamics of pharmaceutical products in humans, i.e.
how the human body absorbs, distributes, metabolizes, and eliminates the drug and how the drug acts on the body to produce its effects. For generic
drugs or reformulated therapies, HVS helps to measure bioavailability and bioequivalence against the 231 innovator reference drug.
We provide the expertise, infrastructure, and operational efficiency necessary to ensure the HVS are conducted safely and in compliance with regulatory guidelines.
Pre-Clinical :- Pre-Clinical comprise in vitro studies (laboratory studies) and in vivo studies (animal studies).
Since Pre-Clinical data guides the design of subsequent Phase I clinical pharmacology studies, Pre-Clinical services compliment our early phase Clinical Trial / HVS services to support biotech and pharmaceutical companies, in order to provide them with comprehensive drug development support.
Biopharma Service :- Biopharma Services provide comprehensive solutions across the drug development cycle for biologics and biosimilars including analytical and functional characterization and clinical bioanalysis.
we have a pan India network of over 280 Clinical Sites and over 550 Clinical Sites globally (including India).
OBJECTS OF THE OFFER
- Capital expenditure towards procurement of equipment and machinery for our Company.
- Investment in our Material Subsidiary, Bioneeds India Private Limited for capital expenditure towards procurement of equipment and machinery.
- Investment in our Material Subsidiary, Bioneeds India Private Limited for repayment/pre-payment, in part or full of certain borrowings of our Subsidiary, Bioneeds India Private Limited.
- Funding organic growth of our Company, our Material Subsidiary, Bioneeds India Private Limited and Health Data Specialists (Holdings) Limited through marketing and promotional activities, updation of technology and adoption of modern digital solutions in our workflows to enhance the efficiency and
quality assurance of our operating processes and data management. - General corporate purposes.
Qualitative Factors
- A platform for drug development needs of customers
- Successful integration of growth opportunities through acquisitions
- Strong scientific capabilities across business services
- Established quality credentials with a strong focus on quality control management
- Global and diverse management team with deep scientific expertise
Comparison of accounting ratios with listed industry peers
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