What is Biosphere CRO?

Biosphere Clinical Research Private Limited is an India-based Contract Research Organisation (CRO) founded in 2012. We provide end-to-end clinical trial services including clinical operations, data management, statistical analysis, regulatory affairs, medical writing, pharmacovigilance, quality assurance, and remote monitoring for pharma and biotech companies globally.

Where is Biosphere CRO located?

Biosphere CRO is headquartered at 405, 4th Floor, Msquare IT Park, Thane (W) 400604, Maharashtra, India. We also have an office in Brampton, Ontario, Canada.

What services does Biosphere CRO offer?

Biosphere CRO offers: Clinical Operations (Phase I–IV), Clinical Data Management, Biostatistics and Statistical Programming, Regulatory Affairs (CDSCO, IND, NDA), Medical Writing, Pharmacovigilance, Quality Assurance (GCP audits), and Remote Monitoring via its proprietary e-Prudent platform.

Is Biosphere CRO registered with CDSCO?

Yes. Biosphere CRO is registered with the Central Drugs Standard Control Organisation (CDSCO) under registration number CROMH2025000019.

Does Biosphere CRO conduct international clinical trials?

Yes. While headquartered in India, Biosphere CRO supports clinical trials globally, including in North America through its Canada office. We have experience with multi-country trials and international regulatory submissions.

Clinical Research Services Provider in India

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Clinical Research Services by Biosphere CRO are designed to deliver high-quality clinical trial solutions in India and globally. Biosphere is a reliable clinical research organisation delivering high-quality clinical trial services in India and globally. Our portfolio of services includes clinical operations, remote monitoring, data management, statistical analysis, regulatory affairs, medical writing, pharmacovigilance and Quality Assurance.

As experienced clinical research consultants, we help our clients with clinical research management and regulatory management expertise. Right from evaluating a project proposal to the closure of the clinical trial with necessary clearances and documentation, we handhold our clients at every stage of the project, making us the best clinical research organisation for end-to-end support.

We have created e-Prudent, a revolutionary online platform for remote monitoring that includes an Interactive Web Response System (IWRS). The e-Prudent system supports Project Managers and Clinical Research Associates (CRAs) to quickly mitigate risks. As a forward-thinking clinical research organisation, we also offer training programmes for project coordinators and sponsors, ensuring efficient execution of clinical trial services across India and globally.

For transparency and regulatory compliance, clinical trials are registered on official platforms such as Clinical Trials Registry

Our Services

Clinical Operation

Biosphere provides end-to-end clinical operation services from site feasibility to close out. Managing clinical operations is a crucial….Continue Reading

Remote Monitoring

A clinical trial is complex in nature. Earlier, traditional methods of monitoring clinical trials were used by sponsors for clinical….Continue Reading

Clinical Research Institute

Biosphere is a reliable clinical research firm providing regulatory and management consulting services for clinical trials….Continue Reading

Data Management

Biosphere provides end-to-end Clinical Data Management (CDM) services with a comprehensive suite of services with a comprehensive….Continue Reading

Statistical Analysis

Statistical analysis and statistical programming play an important role in clinical research data analysis. We at Biosphere….Continue Reading

Regulatory Affairs

At Biosphere, we present to you a team of clinical research professionals with diverse backgrounds and vast experience….Continue Reading

Medical Writing

Be it academic writing, regulatory writing, clinical writing or medical writing for specific projects, our medical writing services….Continue Reading

Pharmacovigilance

Safety is a key component of any clinical trial. The Pharmacovigilance services team at Biosphere helps project sponsors to create….Continue Reading

Quality Assurance

Biosphere appoints a well-experienced Quality Assurance team to ensure that all rules and regulations are being followed….Continue Reading

The clinical trial was well-organized and executed. BiosphereCRO and their team formed a capable, competent, and efficient partner in this process. Thank you very much and I am looking forward to future cooperation!

Milind SinghManager

It has been a pleasure to work with the knowledgeable and dependable staff at BiosphereCRO. Cost-effectiveness and the ability to meet our project timelines were also key considerations in our evaluation.

Nilam SharmaRegulatory Affairs & Quality Assurance Director

Speak to a member of our team about our clinical and safety data services

Our expert will work with you to gain insight to your molecule, anticipated outcomes and definite trial requirements and provide a customised design best suited for your molecule.