Real-world evidence

Yes, as supporting evidence. But you cannot simply export it and submit it. Raw EMR data is everyday hospital data, not clinical evidence. It becomes evidence only when a proper study is built around it. That means a study plan written before analysis, approval from a registered ethics committee, and patient consent or a recorded reason why consent was not needed. The data must also be traceable and open to audit. You must say how patients' identities were protected.

Not on its own. A reviewer asks whether the data fits the question, not just whether it is large. Records from a few large city hospitals may leave out rural patients, primary care and lower-income groups. They may also miss how a disease differs from region to region. A smaller, well-planned study across varied settings, public and private, urban and rural, is often stronger than a large pile of records with no study plan behind it.

It can, so act on it straight away. Data collected while the PI was in post stays valid if it followed the approved plan and the records are complete and signed. Tell the ethics committee about the departure. Appoint a qualified new PI and get approval before collecting more data. If an auditor later finds data collected with no qualified PI, and nobody said so, the whole site's data may be left out of your filing.

Owning the data and having access to it for regulators are two different things. Settle both in writing before the work starts. The company that holds the approval must be able to see all the data behind the filing, including raw data. Regulators may inspect it. If the agreement limits your access, limits what you can submit, or lets the hospital block a filing, you have a regulatory problem. This is true whatever the business deal says.

Yes. It can show how the medicine behaves in Indian patients. This matters most where Indian patients differ from the global data. The data must meet the same standard as any safety evidence. That means a study plan, ethics approval, patient consent, MedDRA coding and case records that can be audited. Informal data passed on by a hospital, with none of this in place, cannot be used in a PSUR.

Before the agreement with the hospital is signed. Ideally before it is even drafted. The agreement decides what the data can be used for. When only legal and business teams write it, the data is often sound but cannot be used for a filing. Common reasons are: the consent form did not cover regulatory use; the data collected did not match what CDSCO needs; the ethics approval was for research only; or the data is not kept long enough. Each of these is easy to fix while drafting. After 18 months of data collection, it is very costly.

If you need evidence from everyday care, yes. If you need help working out your first step, start with our Innovation and strategy service. It covers research results, prototypes and the gap to approval.