Everyone in clinical research knows the obvious delays: slow patient recruitment, data queries, complex monitoring visits. But there is one bottleneck that rarely makes it onto the agenda, even though it can cost weeks: approval management. The back-and-forth with IRBs and ethics committees, tracking submission statuses, collecting signatures. In many organisations, these processes still run on e-mail threads, shared drives, and individual memory. And that comes at a cost.

This is not limited to pharmaceutical trials. The same challenges exist across all forms of human subjects research, studies involving medical devices, diagnostics, or other interventions that require ethics committee approval. The processes are comparable; so are the risks.

Since the EU Clinical Trials Regulation (CTR, Regulation EU No 536/2014) came into full effect in January 2023, the way clinical drug trials are submitted and approved across the EU has fundamentally changed. Through the Clinical Trials Information System (CTIS): the EMA’s central portal: sponsors must now submit and obtain approval for trials across all EU member states through a single application.

The CTR harmonises regulatory requirements across 27 countries. That is progress. But it also introduces new demands: strict statutory assessment timelines, standardised submission formats, coordinated evaluation between member states, and standardised status reporting via CTIS. Organisations that still manage approvals manually will find this increasingly unworkable in multi-country trials.

Managing approvals without a dedicated system feels manageable at first. You know the parties involved, you know which documents are where, and the deadlines are in your spreadsheet or your head. But as studies grow: or when you are managing multiple sites or countries: that approach starts to crack.

Here is what can go wrong:

• An approval renewal lapses because the reminder was in one person’s calendar. That person is off sick. The study continues, technically without a valid authorisation.
• An ethics committee raises questions about a submitted protocol. Answers go back and forth by e-mail, but no one is clearly in charge of the thread. A response from three weeks ago turns out never to have been sent.
• An audit requests the audit trail for a specific approval. The information exists, spread across four inboxes and two shared drives.
• An amendment needs sign-off from multiple sites. Coordination happens manually. One site forgets to sign. The intervention start is delayed.

These are not edge cases. They are recognisable patterns in organisations working without a dedicated system. And while the EU CTR specifically applies to pharmaceutical trials, the same patterns appear in other forms of human subjects research: medical device studies requiring ethics committee approval, observational research with formal review, or multi-centre studies involving several IRBs.

The problem with manual approval processes is that they only become visible when something goes wrong. While everything seems to be running, the system appears to work. But it is quietly consuming time: searching for the latest version of a document, chasing a committee that has not yet signed, reconstructing a timeline for an auditor.

Research by Tufts Center for the Study of Drug Development has shown that administrative and regulatory processes account for a substantial share of total study duration (Getz et al., 2008). Approval workflows are a significant contributor: delay in IRB approval is one of the most frequently cited causes of trial start-up delays (Dilts & Sandler, 2006).

And yet this rarely gets addressed first. Because it does not appear on a dashboard. Because no one can count an e-mail thread. Because work that disappears into the background does not show up in study metrics.

A Regulatory Information Management System (RIMS) brings all regulatory and ethics approval processes into a single central environment. No more scattered e-mail chains, no documents on personal drives, no version conflicts. And for organisations working under the EU CTR: a clear structure that aligns with the timelines, formats and reporting obligations of the CTIS portal.

Specifically, a RIMS changes the following:

Centralised overview per submission

Every submission to an IRB, ethics committee or national authority has its own status view. You can see at a glance what has been submitted, what is awaiting a response, what has been approved and which renewals are coming up. That overview does not depend on one individual: everyone with the right access sees the same information.

Q&A functionality within the system

Questions from an ethics committee are no longer handled by e-mail, but through a built-in Q&A module. Questions, answers and the associated documents sit in the same system as the submission itself. The complete communication history is always traceable.

Shared calendar and deadline management

Approval expiry dates, submission deadlines and review periods are tracked in a shared calendar. Automated notifications ensure deadlines are not missed, regardless of who is responsible at any given time. For CTR-governed trials: where statutory assessment timelines apply: this is not a convenience feature. It is a compliance requirement.

Digital signature with timestamp

Documents are signed via a legally valid e-signature with a timestamp, directly linked to the submission. No more circulating PDFs, no manual verification of whether someone has actually signed.

Inspection-ready audit trail

Every action in the system is logged automatically: who submitted what and when, who approved, which questions were asked and answered. When an inspection takes place, whether from an EMA inspector under the CTR framework or an ethics committee reviewing a human subjects study: there is nothing to reconstruct. It is simply there.

For sponsors and CROs operating under the EU CTR, centralised approval management means multinational submission workflows remain manageable. The regulation requires coordination across multiple member states: which is structurally vulnerable with manual processes. A RIMS gives you the oversight and traceability you need.

For academic institutions and healthcare organisations, managing multiple active studies simultaneously, each with their own committees and timelines: becomes far more workable. Those studies may include pharmaceutical trials governed by the CTR, but also medical device studies, WMO-equivalent research, or other human subjects protocols. In both cases, a central tool makes it possible to delegate management without losing oversight.

And for everyone: if an inspection comes, you do not want to spend a day reconstructing a file. You want everything to simply be there.

Discover how ResearchManager’s RIMS streamlines your regulatory processes, whether you are working under the EU Clinical Trials Regulation or within the frameworks governing other forms of human subjects research. Book a no-obligation demo and see how it works for your study set-up.