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Genelife Clinical Research Pvt. Ltd.

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Genelife Clinical Research Pvt. Ltd.

Your Trustworthy Partner in Product Development! These studies help generate long-term safety, effectiveness, and outcome data.

Genelife® Clinical Research is a global Clinical Research Organization (CRO) in India committed to providing a comprehensive range of clinical trials, real world evidence (RWE) and market research to pharmaceutical, biotechnology, and medical device companies. Our capabilities include clinical project management, clinical operations, patient recruitment and retention, clinical data management, reg

ulatory coordination, and drug safety support for clinical trials. With experience in Phase I–IV studies, we focus on efficient ex*****on, regulatory compliance, and high-quality data generation. In addition to clinical trials, Genelife conducts real-world evidence and observational studies to evaluate product performance in routine clinical practice. Genelife also provides healthcare market research including physician perception studies, treatment pattern analysis, and patient journey research. These insights support product positioning, lifecycle strategy, and commercialization planning. With strong expertise in India and a global research approach, Genelife Clinical Research integrates clinical trials, real-world evidence, and healthcare market research to support end-to-end product development. Why Genelife Clinical Research Pvt. Ltd.

* Integrated clinical trials, RWE, and market research capabilities
* Strong operational expertise in India with global research approach
* Phase I–IV clinical trial support across therapeutic areas
* Patient-centric recruitment and retention strategies
* Flexible and scalable clinical project management
* Quality-driven and compliance-focused ex*****on

Website: https://www.genelifecr.com

29/05/2026

In 2012, Genelife published a perspective on drug–device combination products.

The conclusion then: the benefits justify the complexity. The manufacturing model that made most sense: two distinct facilities, coordinated but separate.

Thirteen years later, we've revisited that article — and the verdict is the same. But almost everything around it has changed.

In 2012, the products were stents, inhalers, prefilled syringes. Today, they include wearable injectors, connected inhalers with real-time adherence tracking, and implantable delivery systems with remote monitoring.

In 2012, cybersecurity was not a consideration. Today, it is a lifecycle regulatory requirement for any digitally integrated device.

In 2012, human factors engineering was a best practice. Today, it is mandatory — and regulators expect structured usability studies that prove patients can use the product correctly in real-world conditions.

The complexity has grown significantly. So has the clinical impact and the commercial opportunity.

Our updated perspective — what's changed, what hasn't, and what it means for your program — is now on the blog.

Drug–Device Combination Products: Challenges and Evolution in Clinical Research

21/05/2026

We published an article on Monday about post-marketing surveillance for biosimilars.
Here's the point that matters most for anyone in this space:
Regulatory approval of a biosimilar is built on a deliberately limited clinical dataset.
That's not a flaw in the system — it's the logic of the abbreviated development pathway. Comparability data reduces the pre-approval burden. Post-marketing surveillance carries the rest.
Which means pharmacovigilance isn't a compliance obligation you manage after launch. It's the second half of your evidence strategy.
The organizations that treat it that way — investing in robust immunogenicity monitoring, structured Phase IV studies, and real-world evidence generation from day one — build market trust that approval alone never could.
The ones that don't find out the hard way that a missed signal or a traceability gap costs far more than the infrastructure they chose not to build.

Understand the importance of pharmacovigilance and long-term safety monitoring in biosimilar development after regulatory approval.

20/05/2026

Reposting our article on the approval process for . As India continues to strengthen its ecosystem, understanding the process is more important than ever.

Learn the CDSCO approval process for clinical trials in India, including regulatory steps, ethics committee approval

19/05/2026

Biosimilar approval is not the finish line.

It's the point at which your pre-approval dataset — intentionally smaller than a novel biologic — meets real patients, real clinical practice, and real immune systems.

What happens next depends entirely on your post-marketing infrastructure:

→ Are you detecting immunogenicity signals before they become safety events? → Is your traceability good enough to link adverse events to the right product? → Are your Phase IV studies generating data that builds prescriber confidence?

PMS isn't overhead. It's the second half of your evidence strategy.

Understand the importance of pharmacovigilance and long-term safety monitoring in biosimilar development after regulatory approval.

15/05/2026

Reposting one of our key insights on selecting the right CRO partner for clinical research programs.

Choosing a CRO is not only about operational support — it directly impacts study timelines, regulatory compliance, data quality, and overall trial success.

In this article, we discuss important factors sponsors should consider while selecting a CRO in India, including therapeutic expertise, regulatory capabilities, clinical operations strength, patient recruitment, and global ex*****on standards.

The decision to outsource clinical trial operations to a Contract Research Organization is rarely difficult. The volume, complexity, and geographic scope of modern clinical development makes full in-house ex*****on impractical for most sponsors.

11/05/2026

Biosimilars are rapidly transforming the global biopharmaceutical landscape, and India is emerging as a key player in this evolution.

Our latest article explores the changing regulatory framework for biosimilars in India, including:
✔ CDSCO & DBT guidelines
✔ Analytical comparability approach
✔ PK/PD-driven development
✔ Reduced clinical burden
✔ Pharmacovigilance & RWE focus
✔ Global regulatory harmonization

As the industry moves toward a more science-driven and risk-based approach, understanding the evolving biosimilar ecosystem becomes increasingly important for sponsors, researchers, and healthcare stakeholders.

Explore India’s evolving biosimilar regulatory framework, including CDSCO guidelines, analytical comparability, PK/PD studies, and pharmacovigilance

07/05/2026

We published an article on Monday about Clinical Project Management in clinical trials.
But one thing stands out from every trial that runs over time or over budget:
The problem is almost never the science.
It's site activation that took 3 months longer than planned. It's a recruitment target that looked achievable on paper — and wasn't. It's data queries that accumulated for months before anyone escalated. It's a regulatory submission that missed a window because two teams weren't talking to each other.
These are coordination failures. And they are entirely preventable — with the right project management structure in place from day one.
If you missed Monday's article, we broke down exactly how end-to-end clinical project management prevents these failures — from feasibility through final reporting.

Genelife provides end-to-end CRO project management services in India and globally

30/04/2026

Accurate and reliable data is the foundation of every successful clinical trial.

Clinical Data Management (CDM) ensures that data collected during clinical trials is clean, validated, and compliant with global regulatory standards. From study setup to database lock, CDM plays a critical role in enabling informed decisions and successful regulatory submissions.

In our latest blog, we explore:
✔ What Clinical Data Management is
✔ Key processes involved in CDM
✔ Its importance in ensuring data integrity and compliance
✔ How CROs support efficient data management

Clinical Data Management in Clinical Trials covering data collection, validation, database management, and reporting processes in CRO services across

27/04/2026

In today’s evolving healthcare landscape, companies need more than controlled data — they need real-world insights and market understanding.

🔍 Clinical Trials → Validate safety & efficacy

📊 Real World Evidence (RWE) → Show real-life performance

📈 Market Research → Reveal physician & patient behavior

When combined, they create a powerful, data-driven strategy across the product lifecycle.

At Genelife Clinical Research, we integrate all three to help sponsors make smarter clinical and commercial decisions.

Genelife, Clinical Research, GCP, Medical Device, Patient Recruitment, Asthma, Oncology, Ophthalmology, Clinical Trials, Cancer, tuberculosis

21/04/2026

Explore the evolution of Indian Regulation

Address

Office No. 12, Ground Floor, Evershine Mall, Chincholi Bunder, New Link Road, Malad West
Mumbai
400064

Opening Hours

Monday	9am - 6pm
Tuesday	9am - 6pm
Wednesday	9am - 6pm
Thursday	9am - 6pm
Friday	9am - 6pm

Website

http://genelifecr.com/

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