The right study does more than generate data. It answers the right question.
Medical device studies have to account for what conventional trial models often miss: operator interaction, workflow, usability, signal quality, device placement and how performance changes across real patient populations.
RhythmRx builds clinical programmes around those realities. We work across the full device risk spectrum, from Class A superficial devices through to Class D implantable and life-supporting technologies, aligning study design with the evidence a submission and a clinical adoption decision will actually require.
Device classes
Across every device class.
Class A
Low risk, non-invasive and superficial devices. Validation focused on performance, usability and labelling claims.
Class B
Low to moderate risk devices. Performance evaluation against reference standards and defined clinical benchmarks.
Class C
Moderate to high risk devices, including many active diagnostic and monitoring technologies. Structured clinical investigation with defined endpoints.
Class D
High risk, implantable and life-supporting devices. Full clinical investigation with rigorous safety monitoring and regulatory oversight.
Classification follows the Indian Medical Device Rules. We also map studies against the equivalent requirements for the markets you are targeting.
Our network
An established clinical network across India.
Evidence is only as good as the sites that generate it. RhythmRx works through long-standing relationships with hospitals, investigators and clinical research partners across India, which lets us match a study to the sites that can actually recruit the population it needs.
Hospital network
Access to tertiary and multi-speciality hospital sites across India, selected against the patient population and clinical setting your study requires.
Investigator and CRO partnerships
Established working relationships with investigators and clinical research organisations, so study teams are assembled from people who have run device studies before.
Sampling and recruitment
Study populations built to your sampling requirement, including sample size, demographic spread, comorbidity profile and site distribution.
Capabilities
What we run.
01
Clinical strategy and study design
Define the clinical question, objectives, endpoints and evidence plan around intended use, claims and the regulatory pathway.
02
Protocol development and ethics approvals
Develop protocols, informed consent documents, case report forms and the full submission set. Prepare and manage Ethics Committee submissions, respond to queries and secure approvals across every participating site, including CTRI registration end to end.
03
Clinical validation and performance evaluation
Validate device performance against reference standards and clinical benchmarks. Comparative and equivalence studies, accuracy and agreement analysis, and validation evidence packaged for submission.
04
Site setup and clinical data acquisition
Site initiation, investigator and staff training, device deployment and hands-on support during data acquisition. Our team is present at site through the acquisition period, not just at initiation.
05
Monitoring, data management and biostatistics
Study monitoring, source data verification, data capture and cleaning, statistical analysis and interpretation against predefined objectives.
06
Post-market and real-world evidence
Post-market clinical follow-up and real-world evidence programmes supporting ongoing safety, performance and clinical claims.
CTRI registration
Registered successfully, and compliantly.
End-to-end assistance with Clinical Trials Registry India, from protocol review through to the granted registration number.
01
Pre-registration
We review your study protocol to extract the dataset requirements and verify that your Ethics Committee approval letters meet CTRI formats.
02
Portal submission
We handle the complete data entry across every mandatory field on the CTRI portal and coordinate the email verifications required from your site principal investigators.
03
Query management
We track the application and draft precise responses to any queries or clarifications raised by CTRI reviewers, until the official registration number is granted.
What you get
What you receive.
Approved protocol and ethics documentation.
Monitored, source-verified clinical dataset.
Statistical analysis report.
Submission-ready clinical evidence package.
Next step
Planning a clinical study?
Tell us the claims you need to support. We will tell you what evidence they will take.