Quorum vs outsourcing pharmacovigilance
For most first-time biotechs the real decision is not which safety database to buy. It is whether to run pharmacovigilance at all, or hand it to a provider. That is a legitimate choice and for some companies it is the right one.
Outsourcing solves a real problem immediately, and one of those problems is legal rather than practical: a sponsor outside the EU needs an EU-resident qualified person, and a provider supplies one without a hire. You also get trained people, a validated system, and coverage across time zones. For a company with one product, a handful of cases a month and no safety team, that is often simply correct. Anyone telling you outsourcing is always wrong is selling you something.
| DIMENSION | Quorum | outsourcing to a CRO |
|---|---|---|
| Regulatory accountability | Yours, with the full trail in a system you control | Still yours — under 21 CFR 314.80 the applicant must review all adverse experience information it receives from any source1 |
| Audit obligation | One system, inside your own quality system | Subcontracted activities sit inside your pharmacovigilance system and must be audited by or for you2 |
| Contract documentation | One agreement, published terms | Since February 2026, EU rules require subcontracting arrangements — and onward subcontracting — to be specified in writing3 |
| Effort per case | AI assembles the case; a reviewer approves it | A person builds each case by hand — roughly one ICSR an hour, longer when complex4 |
| Cost behaviour as volume grows | Platform fee plus a published per-case rate | Broadly linear — more cases means more billed effort5 |
| Continuity of the people | Your team, and the audit trail keeps the reasoning | Providers themselves advise checking a vendor’s team and turnover history before signing6 |
- 21 CFR 314.80(b) — “Each applicant having an approved application … must promptly review all adverse drug experience information obtained or otherwise received by the applicant from any source” · checked 27 Jul 2026
- EMA — Good Pharmacovigilance Practices Module I, section I.C.1.5, “Quality system requirements for pharmacovigilance tasks subcontracted by the marketing authorisation holder” · checked 27 Jul 2026
- Commission Implementing Regulation (EU) 2025/1466 on pharmacovigilance subcontracting — in force 12 Aug 2025, fully applicable 12 Feb 2026 (summary; verify article numbers before quoting verbatim) · checked 27 Jul 2026
- DataFoundry — manual intake takes 15–40 minutes for a simple ICSR and up to four hours for a complex case; a reviewer processes roughly one ICSR an hour · checked 27 Jul 2026
- Indegene — case processing consumes 40–80% of PV budgets; case volumes growing 10–15% a year · checked 27 Jul 2026
- PrimeVigilance — guidance on selecting a PV provider, advising buyers to review the actual team, CVs and turnover history · checked 27 Jul 2026
Choose outsourcing to a CRO if…
You have no safety team, a small and predictable case load, and more urgent places to put your next hire — or you are a non-EU sponsor who needs an EU-resident qualified person and does not want to recruit one. A good provider keeps you compliant from day one and carries the operational burden entirely. If your volume is genuinely low and likely to stay low, the arithmetic often favours outsourcing, and we will say so on the call rather than after it.
Choose Quorum if…
You want the capability in-house without the headcount it used to require. Outsourcing moves the work, not the accountability: the applicant still has to review every adverse experience report it receives from any source, subcontracted activity still sits inside your pharmacovigilance system, and since February 2026 the EU expects the whole subcontracting chain documented in writing. Running the system yourself means the record, the data and the reasoning stay where the responsibility already is.
Outsourcing buys capacity, and it works. What it does not buy is control of the record or a cost base that stops tracking your case volume — and it never transfers the regulatory responsibility, which is yours either way.
Common questions.
- If we outsource pharmacovigilance, who is responsible to the regulator?
- You are. Under 21 CFR 314.80(b) the applicant must promptly review all adverse drug experience information it obtains or receives from any source — a vendor reporting into you does not change who the applicant is. In the EU, tasks subcontracted by the marketing authorisation holder remain part of the holder’s pharmacovigilance system, and auditing those organisations is part of your own audit programme.
- What changed in the EU rules on outsourcing?
- Commission Implementing Regulation (EU) 2025/1466 entered into force in August 2025 and became fully applicable in February 2026. It requires subcontracting arrangements to specify roles, data exchange and audit rights in writing, and applies down the chain to onward subcontracting. If your provider relationship predates that and the paperwork has not been revisited, it is worth asking about.
- Can we use Quorum and keep a provider?
- Yes, and several teams should. A common pattern is to run the system yourself and use a provider for out-of-hours coverage, volume peaks, or specialist medical review. Because we do not charge per user, adding your provider’s reviewers to your instance costs nothing extra — and the audit trail stays in one place.
See the difference on a real case.
Bring one of your own, de-identified. Thirty minutes, end to end.