Oncology Clinical Research · India
Oncology CRO in India for Cancer Clinical Trials
Shen Clinical Services is a physician-led oncology CRO in India. We plan and run cancer clinical trials from Phase I to Phase IV, in solid tumours and blood cancers, covering protocol design, CDSCO and ethics approvals, site selection, monitoring, data management, safety reporting and medical writing.
15.7 lakhNew cancer cases, 2025 estimate
287National Cancer Grid members
90 working daysCDSCO trial decision
Phase I to IVSolid tumours and blood cancers
On this page
Why India
Why Run Oncology Clinical Trials in India
India combines a large cancer patient population, an organised network of cancer centres and a time-bound approval process.
Large Patient Pool
ICMR’s National Cancer Registry Programme estimates about 15.7 lakh new cancer cases in India in 2025, which supports faster enrolment across tumour types.
Organised Cancer Centres
The National Cancer Grid links 287 cancer centres, research institutes and patient groups that together treat more than 60% of India’s cancer patients.
Time-Bound Approvals
CDSCO decides on a trial application within 90 working days, or 30 working days for drugs discovered and developed in India.
Global-Standard Data
Trials follow Indian GCP, ICMR ethical guidelines and ICH GCP, with registered ethics committees and mandatory CTRI registration.
Approvals
Oncology Clinical Trial Approvals in India
Every cancer clinical trial in India needs these approvals and safeguards, set by the New Drugs and Clinical Trials Rules, 2019:
| Requirement | What it involves | Rule / timeline |
|---|---|---|
| Trial permission | Application in Form CT-04 to CDSCO, reviewed with the Subject Expert Committee; permission granted in Form CT-06 | 90 working days (Rule 22); 30 working days for India-developed drugs (Rule 23) |
| Ethics approval | Approval from a CDSCO-registered ethics committee for each site | Before the trial starts (Rule 25) |
| CTRI registration | Registration on the Clinical Trials Registry – India, run by ICMR | Before the first patient is enrolled (Rule 25) |
| Informed consent | Written consent, with audio-video recording where the Rules require it, such as for vulnerable participants | Throughout enrolment |
| Safety reporting | Every serious adverse event reported to CDSCO, the sponsor and the ethics committee | 24 hours; analysed report within 14 days (Rule 42) |
| Compensation | Free medical management and compensation for trial-related injury or death | Chapter VI of the Rules |
Cancer drugs already approved in the US, UK, EU, Japan, Australia or Canada may qualify for a local clinical trial waiver under CDSCO’s August 2024 order. Our regulatory affairs services team can assess the best approval route for your molecule.
Trial Design
Cancer Clinical Trial Designs We Support
Oncology studies rarely fit a standard template. We design each trial around the molecule, the tumour type and the decision you need to make next:
- Phase I dose finding: dose escalation and expansion cohorts in patients, with safety review committees
- Adaptive and master protocols: basket, umbrella and platform designs that add or drop arms on interim data
- Biomarker-driven studies: enrichment and stratification by mutation or expression status
- Phase II and III efficacy: endpoints such as objective response (RECIST 1.1), progression-free survival and overall survival
- Immuno-oncology: immune-related response assessment and immune adverse event management
- Haematology: leukaemia, lymphoma and myeloma studies with disease-specific response criteria
- Oncology biosimilars and generics: comparative efficacy and patient bioequivalence studies; see biosimilar development
Learn more about our clinical trial protocol design service.
Our Process
How We Run Your Oncology Clinical Trial
STEP 01
Feasibility and Sites
We assess patient numbers and standard of care, then select oncology sites and investigators.
STEP 02
Protocol and Approvals
We write the protocol and file for CDSCO permission, ethics approvals and CTRI registration.
STEP 03
Conduct and Monitor
We start up sites, train teams and monitor enrolment, dosing, imaging and source data.
STEP 04
Data, Safety and Reports
We manage data, report serious adverse events on time and deliver the clinical study report.
Why Shen
Why Choose Shen as Your Oncology CRO in India
Physician-Led Oversight
Medically qualified team members review protocols, eligibility and safety signals throughout the study.
Regulatory Under One Roof
The same team handles CDSCO, ethics and CTRI filings and answers expert committee queries.
Cancer Centre Network
We work with investigators at oncology hospitals and cancer centres across India.
One Partner, Full Service
Monitoring, data management, pharmacovigilance and medical writing from a single team.
What We Cover
Our Oncology Clinical Research Services
Feasibility and site selection
Protocol and study design
CDSCO trial permission
Ethics committee submissions
CTRI registration
Site start-up and monitoring
Clinical data management
Biostatistics
Pharmacovigilance and SAE reporting
Medical writing and CSRs
Investigator brochures and consent forms
Local trial waiver applications
FAQs
Oncology Clinical Trials in India: Frequently Asked Questions
Can overseas sponsors run cancer clinical trials in India?
Yes. An overseas sponsor applies to CDSCO through an authorised Indian representative, such as a CRO, which files Form CT-04, obtains ethics approvals and registers the trial on CTRI. Shen can act as that local partner and manage the trial in India.
How long does CDSCO take to approve an oncology trial?
Under Rule 22 of the New Drugs and Clinical Trials Rules, 2019, CDSCO decides within 90 working days of the application. For drugs discovered in India, or researched and to be manufactured and marketed in India, Rule 23 sets 30 working days. Ethics approvals and CTRI registration run alongside.
Does a cancer drug approved abroad need a clinical trial in India?
Not always. Under an August 2024 order made under Rule 101, CDSCO may waive the local clinical trial for new drugs already approved in the US, UK, EU, Japan, Australia or Canada, in categories that include orphan drugs, gene and cell therapies, and drugs offering a significant therapeutic advance over the current standard of care. The waiver is decided case by case.
Is CTRI registration mandatory for oncology trials?
Yes. Rule 25 requires every clinical trial to be registered on the Clinical Trials Registry – India, maintained by ICMR, before the first patient is enrolled.
How are serious adverse events reported in Indian cancer trials?
The investigator must report every serious adverse event to CDSCO, the sponsor and the ethics committee within 24 hours, followed by an analysed report within 14 days, as set out in Rule 42. Trial-related injury or death also triggers free medical management and compensation.
Are oncology bioequivalence studies done in patients?
Often, yes. Many cytotoxic cancer drugs are too toxic to give to healthy volunteers, so bioequivalence studies for their generics are run in patients who are already receiving the drug, at oncology sites with the right clinical support.
Resource Spotlight
Developing a biologic for cancer? See our biologics registration in India service and our full range of clinical trial services in India.
Start Your Oncology Clinical Trial in India
Planning a cancer study? Share your protocol synopsis for a feasibility and budget estimate.
Running a global trial? We can add Indian sites and manage them locally.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: Lok Sabha reply on ICMR-NCRP cancer estimates (March 2025); PIB factsheet on cancer care and the National Cancer Grid; New Drugs and Clinical Trials Rules, 2019 (CDSCO); DCGI order on local clinical trial waivers (August 2024); Clinical Trials Registry – India. General regulatory information, not legal advice.