Clinical trials
Clinical trials (CRO)
We are a CRO (contract research organisation: a company that runs trials for others). We run studies in people for medicines, medical devices, nutraceuticals and cosmetics, from the study plan to the final report.
What it is
In one sentence
We plan your clinical trial, get it approved, run it at hospital sites, check the data and write the final report.
Who it is for
Clinical operations leads at pharma, medtech, nutraceutical and cosmetic companies. Also teams that need to test software that counts as a medical device.
Problems it solves
Why trials run late, and how we prevent it
Approvals take longer than planned
Ethics committee approvals, CDSCO approval and the import of the study product all take time. We map each step against real timelines before the study starts.
Sites do not recruit
Sites are often chosen on hopeful numbers. We choose sites on how many patients they actually recruited in past studies.
Safety reports sent late
A serious adverse event (a serious medical problem during a trial) must be reported fast. We check each one for seriousness and cause, and send it on time.
What you get
Deliverables
- Protocol writing and a feasibility check (can this study be done, where and how fast)
- Ethics committee and CDSCO submissions
- Site selection, set-up and start-up
- Monitoring visits by CRAs (clinical research associates: staff who check each site follows the protocol)
- Handling of adverse events and serious adverse events
- Data management and statistical analysis
- The clinical study report (CSR): the final report of the study
- Project management from start to finish
- Clinical validation of software as a medical device
- Decentralised options, such as video visits and home nursing, where the rules allow
How it works
From study plan to final report
Check feasibility
We review your study idea and write a feasibility report. It maps each milestone, from approvals to the first patient.
Get approvals
We prepare and file the submissions to the ethics committees and to CDSCO.
Set up the sites
We choose sites on their real recruitment record. We train the site teams and open each site.
Run and monitor
Our CRAs check each site. We track every milestone and act early if a site falls behind. We handle safety events as they happen.
Analyse and report
We clean and lock the data, run the statistics and write the clinical study report.
Regulators and standards
Rules we work to
- CDSCO (India)
- The Central Drugs Standard Control Organisation. It approves clinical trials of new medicines and devices in India.
- New Drugs and Clinical Trials Rules, 2019
- India's main rules for running clinical trials of medicines, including how to report serious adverse events.
- Medical Devices Rules, 2017
- India's rules for medical devices, including clinical investigations (trials of devices).
- ICH Good Clinical Practice (GCP)
- The international standard for running trials that are safe for people and give data you can trust.
- Ethics committees
- Each site's ethics committee must approve the study before any patient joins. It protects the people in the trial.
- Terms explained
- Phase I to IV: the stages of testing a medicine, from the first small studies to monitoring after it is on sale. BA/BE: studies that check how much medicine reaches the blood, and whether two versions act the same. SAE: a serious adverse event. EDC: electronic data capture, the system sites use to enter study data. DCT: a decentralised trial, where some visits happen at home or online.
Proof
Proof
TrialGuna is a CDSCO-registered CRO (Reg. No. CRO/KA/2025/000030). We work with 50+ clinical trial sites and 40+ partner hospitals across India.
Our site network
Hospitals and research sites
We run studies with 62 hospitals and research sites across 8 states in India.
Andhra Pradesh
- GMC & GGH HospitalSrikakulam
- Medigene Multispeciality HospitalVisakhapatnam
Gujarat
- VitelySMO (Network Sites)Ahmedabad
- Vivoclin Research Services LLPAhmedabad
- Basil Onco Care & Research InstituteSurat
- Parul University Clinical Trial CentreVadodara
- SSG Hospital (Sir Sayajirao General Hospital)Vadodara
Karnataka
- KIMS Hospital BelagaviBelagavi
- KLE HospitalBelagavi
- Apollo HospitalBengaluru
- Asha Hospitals and Research CentreBengaluru
- Cutis HospitalBengaluru
- DG HospitalBengaluru
- Fortis HospitalBengaluru
- HCG Hospital (Bangalore Inst. of Oncology)Bengaluru
- MS Ramaiah HospitalBengaluru
- Maayra Emotional Wellness CentreBengaluru
- Minto Ophthalmic HospitalBengaluru
- NRR HospitalBengaluru
- Pranav Diabetes CenterBengaluru
- Ratkal Speciality Hospital (Rescue Urology Hospital)Bengaluru
- Roshni Speciality ClinicBengaluru
- Rutheek Children CareBengaluru
- SDM Institute of Ayurveda and HospitalBengaluru
- Sankalpa HospitalBengaluru
- Sri Maruti ClinicBengaluru
- Sri Shankara Cancer HospitalBengaluru
- Srinivasam Cancer Care Multispeciality HospitalBengaluru
- St. Johns Medical College HospitalBengaluru
- Tara Day Care HospitalBengaluru
- Trauma & Emergency Care Centre, Victoria HospitalBengaluru
- Vaayu Chest & Sleep SpecialistsBengaluru
- Vani Vilas HospitalBengaluru
- Victoria HospitalBengaluru
- Hassan Institute of Medical SciencesHassan
- SDM College of Ayurveda and HospitalHassan
- Karnataka Medical College & Research InstituteHubli
- R L Jalappa Hospital (Devaraj Urs Medical College)Kolar
- Adichunchanagiri HospitalMandya
- Kasturba Medical College HospitalMangaluru
- Bharath Hospital & Institute of OncologyMysuru
- JSS HospitalMysuru
- K R HospitalMysuru
Kerala
- Trivandrum Medical CollegeTrivandrum
Maharashtra
- Jeevan Amrut Hematology CentreAurangabad
- MGM Medical College & HospitalAurangabad
- Ascent Clinical Research / Dr D Y Patil Medical CollegeKolhapur
- Datta Meghe Clinical Research Dept.Nagpur
- Terna Speciality Hospital & Research CentreNavi Mumbai
- Punawale Multispecialty HospitalPune
Tamil Nadu
- Bewell HospitalChennai
- G. Kuppuswamy Naidu Memorial Hospital (GKNM)Coimbatore
- KG HospitalCoimbatore
- VGM HospitalCoimbatore
- GVN Riverside Multispeciality HospitalTrichy
Telangana
- Citizens Specialty HospitalHyderabad
- KIMS Hospital HyderabadHyderabad
- Yashoda HospitalHyderabad
Uttar Pradesh
- Arvachin HospitalVaranasi
- Ford HospitalVaranasi
- Gangoshri HospitalVaranasi
- Janta Hospital & Maternity CentreVaranasi
FAQs
Questions we are often asked
Which kinds of study do you run?
Phase I (including BA/BE) to Phase IV. We also run clinical investigations of medical devices, and efficacy studies for nutraceuticals and cosmetics. Efficacy studies test whether a product does what it claims.
Can you run the whole trial, from protocol to final report?
Yes. We cover the feasibility check and protocol, ethics and CDSCO filings, site set-up, monitoring, safety events, data management, statistics and the clinical study report. Our regulatory and drug safety teams work with the trial team. So your trial data, safety reports and filing plan match from the start.
Do you have a site network we can review?
Yes. We work with 50+ clinical trial sites across India. We share the sites that fit your study during the feasibility check. See the full list of sites on this page.
How big is your clinical operations team?
A core team of 35+ people: CRAs, project managers, data managers and site liaisons. A head of clinical operations with 15+ years of GCP trial experience leads it. We add capacity for each study through our site network and partners.
How do you handle serious adverse events, even outside office hours?
We take in serious adverse event reports 24 hours a day, 7 days a week. A medically qualified reviewer is always on call. Our own target is a full, reviewed report to the sponsor by Day 5, so there is time to spare before the legal deadline. We check each event for seriousness, cause and whether it was expected. We then report it to CDSCO and the ethics committee on time.
Trials in India often run late. How do you prevent that?
We tackle the two main causes: slow approvals and sites that do not recruit. Every study starts with a written feasibility report. It maps each milestone against real Indian timelines. We choose sites on their past recruitment, not on promises. We track every milestone and step in early when a site falls behind.
Do you offer decentralised trial options?
Yes, where the rules allow. Options include video visits, ePRO (patients report their symptoms on a phone or tablet), home nursing through partners, and delivery of the study product to the patient's home.
Which therapy areas do you know best?
Dermatology, women's health, cognition, healthy ageing, men's health, wound healing, personal care, gut health, metabolic, respiratory, and supportive care in cancer. We also run other nutraceutical studies.
Is your EDC system 21 CFR Part 11 compliant?
21 CFR Part 11 is the US rule for electronic records and signatures. We collect study data in EDC (electronic data capture) systems from vendors who validate them for 21 CFR Part 11, with a full audit trail. We keep the vendor's evidence on file.
Do you also test usability or child-resistant packaging?
Yes, but on a different page. See Human factors and packaging.
These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.
Related services
Often used together
-
Pharmacovigilance
Use this when you hold a marketing licence and must track and report side effects.
Learn more about Pharmacovigilance → -
Regulatory affairs
Use this when you need a product approved, a licence renewed, or an audit passed.
Learn more about Regulatory affairs → -
Human factors and packaging
Use this when you need usability studies or child-resistant packaging tests.
Learn more about Human factors and packaging →
Start a conversation
Talk to a clinical operations lead.
Tell us about your product and the study you have in mind. We will check if it can be done, where, and how long it will take.