Quality systems built for how clinical research actually runs
Clinical research doesn't work like manufacturing. You're running projects rather than production, for different sponsors with different expectations, and the pause between studies that would let you fix anything doesn't exist.
Clinical quality sits under GCP rather than manufacturing GMP, and the difference matters. This page is about clinical research quality systems.
I help CROs build a quality management system that works across studies, assess the one they already have, and coach research teams on quality management and data integrity.
28 years in life sciences across three continents
What I hear from CROs
Every sponsor expects something slightly different
Quality processes vary from study to study
Data issues surface late, when they're most expensive
New staff learn on live studies
Vendor oversight is unclear
A gap assessment identified problems and nobody has the expertise to close them
Why this happens in clinical research
Project-based work resists standard systems.
Every study has its own shape, so processes get rebuilt each time and nothing accumulates.
Growth came through people rather than process.
You hired good people and they made it work. That scales until it doesn't.
Scientific expertise isn't quality systems expertise.
Plenty of CROs have excellent technical and trial management capability and no one who has built a quality management system before. Those are different skills.
There's no pause between studies.
The gap where you'd fix things is occupied by the next study.
What I do for CROs
Build a quality management system.
A phased approach: mapping your processes and defining roles first, then a quality manual, an SOP framework, quality review processes, and the governance structure underneath it. Sized for how you actually run studies rather than lifted from a manufacturing model.
Assess the system you already have.
Against the regulatory requirements that apply to you, with the gaps ranked so you know what to deal with first.
Set up the parts that usually get left out.
Quality metrics, document control, and planning for system validation. These are the pieces that make a QMS maintainable rather than just documented.
Coach your staff.
On quality management and data integrity, built around your own procedures rather than generic GCP material.
What a clinical quality system has to do
Work the same way across every study.
So quality doesn't depend on who's running it.
Absorb sponsor requirements without rebuilding.
A system flexible enough to take a new expectation without starting again.
Make data reliable while it's being collected.
Not reconstructed afterwards when a query comes in.
Bring new staff up to standard quickly.
Because they're going to be on a live study either way.
Where this connects
Design and implementation of tailored quality systems
When processes vary study to study and nobody can say which version is right.
Data integrity assessments
When data problems keep surfacing after the fact rather than during.
Proof
A quality management system for a university-based CRO expanding into commercial trials
An investigator-led CRO based at a university was expanding its clinical trial services to take on commercial sponsors, and wanted to offer full trial management. The scientific and technical expertise was already there. The quality systems expertise wasn't, and an independent gap assessment had identified several major gaps they needed to close. They wanted to close them properly, with systems that were fit for purpose rather than borrowed.
I interviewed staff to understand how the business actually ran and what internal resource they had, reviewed the existing gap assessment, and mapped the key processes to find the real issues. Then coaching and brainstorming sessions with key staff, working through potential solutions using the process maps, before drafting SOPs based on what came out of those sessions, what compliance required, and how the organisation actually works. Regular meetings with stakeholders throughout to check progress and answer questions as they came up.
They ended up with a quality management system suited to the services they were actually offering. The existing gap assessment was used to close out the major findings rather than repeated, so the work they'd already paid for counted. And clear roles and responsibilities came out of it, which let them plan recruitment and write job descriptions.
CLIENT PERSPECTIVE
"The results were outstanding and the support was beyond the scope of the agreement. The structured, phased approach provided clear guidance from initial process mapping and role definition through to the development of a comprehensive Quality Manual, SOP framework, quality review processes, and staff training. Antiksha demonstrated exceptional expertise in clinical trial quality management, taking the time to understand our organisation and tailor solutions to our specific needs."
Melbourne-based CRO
How an engagement runs
01 / 05
A conversation.
Thirty minutes on how your studies actually run, how many sponsors you work with, and where quality is inconsistent.
02 / 05
Understanding the operation.
Staff interviews and process mapping. How the work happens now, who owns which part of it, and what internal resource you have to work with. If you've already had a gap assessment, I'll use it rather than repeat it.
03 / 05
Working through solutions together.
Coaching and brainstorming sessions with your key people, using the process maps. The solutions come out of those sessions rather than arriving finished.
04 / 05
The framework.
Quality manual, SOP structure, review processes and governance, drafted from what those sessions produced. Plus quality metrics, document control and a plan for validating the systems you rely on.
05 / 05
Coaching and handover.
Your staff coached on the system they'll be running, using your own procedures. Regular check-ins throughout rather than a handover at the end.
Who you'd be dealing with
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
I've built quality management systems for clinical research organisations and coached research teams on quality management and data integrity.
Questions CROs ask
What quality system does a CRO actually need?
One that works the same way across studies and can absorb a new sponsor's expectations without being rebuilt. Underneath that: a quality manual, an SOP framework, review processes, and a governance structure that someone owns.
We've had a gap assessment. Do we have to start again?
No. If you've already had one, it's a starting point. I'd rather use it to close out the findings than charge you to discover the same things twice.
How do we keep data reliable across multiple studies?
Usually by fixing the workflow rather than adding review steps. Data problems that surface late are almost always workflow problems that started early.
How do we train research teams without slowing studies down?
Short, role-specific, built around your own procedures, with reinforcement afterwards. Generic GCP training delivered in a block doesn't change behaviour.
Does GMP apply to us?
Sometimes, in part, depending on what you handle. It's a fair question and a lot of CROs aren't sure. Worth a conversation rather than an assumption.
How do we handle different sponsor requirements?
By building a system that treats them as variations rather than as exceptions. The alternative is a different process per sponsor, which is where most CROs end up.
What about quality metrics and document control?
Both are part of the work. They're the difference between a QMS that stays current and one that gets built and then drifts.
