How Contracted Insourcing is Making Clinical Operations More Efficient
More sponsors are embedding consultants directly into their ClinOps functions as a faster, more flexible alternative to FTEs or full outsourcing. Here's what that looks like in practice.
Many sponsors we talk to still think about resourcing their ClinOps functions in one of two ways: Either open a full-time req and wait, or outsource the work. But we've seen more teams moving away from that binary, and the companies getting it right are the ones using some form of a third option: embedding full-time clinical professionals on contract. “Insourcing,” as some call it (although that term means different things to different people).
To us in this context, it means bringing someone into your org chart, reporting to your ClinOps lead, and doing the same work a permanent hire would do. The difference is speed (filling the seat in weeks instead of months) and flexibility (you define the scope and duration).
There’s some data to back this up:
A 2023 study published in Applied Clinical Trials by colleagues at Tufts CSDD and ICON found that pivotal trials managed under full-service outsourcing arrangements averaged 1 year longer and were more complex than those run under other models.
An earlier ACT survey found that 80% of sponsors have already been using a combination of outsourcing and insourcing models, with only 11% relying on a purely full-service approach as of ~2010.
With the old binary “broken,” the question we field from sponsors is: what’s the right blend of insourcing and outsourcing for our situation?
Based on how we’ve placed consultants at sponsors ranging from pre-IND biotechs to mid-size pharma companies with active Phase III programs, here are six distinct ways the embedded model works in practice.
Few we jump in, we sat down with Mark Shapiro a few years back, then a Partner with biopharma consulting firm Pharma Initiatives (now SVP and GM at Tempus AI), to discuss outsourcing and insourcing models in the current clinical R&D environment, and what to consider when selecting the right model or mix of models for a project.
If you haven’t already, catch that conversation first:
📄 Read our companion white paper: A Modern Guide to Clinical Operations Resourcing. We also have a column on the subject in Clinical Leader.
1. Full-time Clinical Operations staff augmentation
We see these situations play out quite a bit: Your Clinical Operations Manager leaves for another company, or you’re scaling from one trial to three, and your existing team can’t absorb the workload. Either way, the work needs to happen now, and recruiting is telling you it’ll be three to five months before someone starts. That’s often just too long a time when you have sites enrolling patients and regulatory milestones on a fixed calendar.
We’ve helped firms in those kinds of binds embed a full-time consultant into the role, whether that’s a Clinical Operations Manager, Senior Manager, or general Clinical Operations Support.
They report to your internal leadership, use your systems and SOPs, and manage the same deliverables a permanent hire would own. That last part matters a lot since using the client’s own processes, systems, and SOPs makes it easy to scale staff augmentation without introducing the coordination burdens that come with outsourced models.
We’ve placed full-time Clinical Operations Managers at sponsors who needed experienced leadership on day one.
One engagement placed a Clinical Ops Manager at a biotech running active trials, and the placement ran for months longer because the consultant stayed through an extended program phase.
Another placed a Senior Manager of Clinical Operations at a sponsor scaling its pipeline. That one gave the company immediate senior-level ClinOps capacity while they continued recruiting for a permanent hire.
These usually aren’t short stints. When a consultant is embedded full-time, the engagement often extends because the sponsor realizes the arrangement is working and the program still needs the coverage after the expected end date.
2. Part-time Clinical Operations support
Not every situation calls for a full-time hire. A smaller biotech running a single trial, or a company that needs specific help with submission support, trial planning, or site management oversight for a few months shouldn’t have to choose between overpaying for capacity they don’t fully use and going without.
A part-time consultant picks up a defined scope within your ClinOps function, maybe 15 to 25 hours a week, maybe scoped to a specific deliverable.
We recently placed a part-time consultant for clinical trial support at a smaller sponsor for a comparatively modest rate. That gave the company access to an experienced ClinOps professional without what would have been a six-figure all-in cost of a full-time hire. We’ve done similar placements for part-time clinical project management and investigator-facing planning work.
This part-time model is especially useful for companies between major trial phases, or those that need a specific skill set (eTMF cleanup, for example) for a defined period. You get real Clinical Operations capacity at a cost that matches your current workload, and you can scale up later if the program grows.
It’s a natural scaling path: a company might start with one insourced functional leader in Phase 1, scale up its internal expertise in Phase 2 as needs grow, and shrink the contingent workforce back down in Phase 3.
3. Clinical Project Managers and Clinical Trial Management
Here’s another scenario we’ve seen multiple times: Your trial is running, but nobody is clearly owning the project management layer.
Timelines are tracked in spreadsheets that three different people update.
Your eTMF has gaps that keep growing.
Your Clinical Operations lead is spending half their time on project coordination instead of the strategic work they were actually hired to do. “Working on the work.”
CPM and CTM roles just sort of naturally sit at the intersection of project management and clinical execution, and they’re some of the most natural fits for embedded consultants.
CPMs tend to focus on timelines, milestones, cross-functional coordination, and status reporting. CTMs tend to focus on eTMF oversight, trial documentation, and the operational mechanics of trial management.
A few months ago, we placed a full-time Clinical Project Manager at a sponsor running multiple active studies. The CPM managed day-to-day trial operations, including milestone tracking, vendor coordination, and internal reporting.
On the CTM/eTMF side, we placed a full-time consultant at a sponsor that needed dedicated eTMF and Clinical Trial Management support. The sponsor extended it with us because the eTMF work took longer than they’d originally scoped. (If you’ve ever been through an eTMF migration or remediation, that won’t surprise you.) But the point is that the model made it easy to arrange that extension as a simple contract amendment.
We’ve seen a broader strategic advantage here, too. A well-placed contract Clinical Operations Manager or contract Project Manager is function-specific and ingrained as an extension of the company. That’s a different animal than an outsourced project manager working through a CRO, who is also juggling other clients and operating within the CRO’s systems rather than yours.
4. In-house CRAs, site-facing roles, and investigator support
The gap between “we outsource monitoring to a CRO” and “we have a full in-house monitoring team” is usually pretty wide, and a lot of sponsors sit in that gap without a good solution. You want more visibility into what’s happening at your sites, but you don’t have the headcount to support a full internal CRA team.
This is also where the CRO dependency risk becomes real. Many companies, especially those in competitive or niche therapeutic areas, need someone from the sponsor side to participate in relationship activities with investigators and sites. When a CRO owns all of those relationships, the sponsor becomes dangerously reliant on specific CRO personnel who might rotate onto other projects or leave entirely. We see this all the time.
An embedded CRA or site-facing consultant is different from a contract monitor working through a CRO. This person reports to you, uses your systems, and builds relationships with your sites as a representative of the sponsor, not a third party.
We’ve placed in-house CRAs at sponsors who wanted monitoring oversight closer to home, and we’ve placed clinical specialists and consultants in clinical/medical affairs roles, including an Associate Director/Director-level Clinical and Medical Affairs consultant at a company that needed senior clinical leadership but wasn’t ready to commit to a permanent hire at that level.
The consultant knows your protocols, your systems, and your sites. That institutional knowledge actually stays with you, even if the consultant’s engagement eventually ends, because the relationships and documentation are built under your roof, not the CRO’s.
5. Clinical supply coordination and vendor oversight
Clinical supply management is one of those functions that doesn’t get much attention until something goes wrong. Then it gets a lot of attention very fast! When a depot shipment is delayed, a site runs out of IP, or a supplier qualification audit is overdue, your Clinical Operations team suddenly spends a lot of time managing supply chain logistics instead of running the trial.
Vendor oversight has a similar dynamic:
Your sponsor obligations include qualifying suppliers, auditing clinical services vendors, and maintaining documentation for inspection readiness.
When nobody owns that work explicitly, it either falls to your QA team (who may not have a clinical trial context) or your ClinOps team (who don’t have the bandwidth).
This is exactly the kind of under-resourcing problem we warn about:
The costs of remediating issues from a project being under-resourced often dwarf the cost of bringing someone in to handle it proactively.
We’ve placed a Clinical Supply Coordinator at a sponsor that needed someone to own the supply chain side of trial operations, everything from depot logistics to site-level tracking.
On the vendor side, we’ve done clinical supply services audits (including one at a European manufacturing site), supplier qualification audits, and clinical site/vendor audit engagements at multiple sponsors.
These are very different scopes, but they share a common thread: somebody at the sponsor realized this work wasn’t getting done well and brought in a consultant to own it.
6. Clinical QA and GCP QA roles alongside Clinical Operations
Clinical QA and GCP QA aren’t part of Clinical Operations on the typical org chart, but in practice, the quality of your trial operations is inseparable from the work these roles do. When they’re absent, ClinOps absorbs the consequences! GCP compliance gaps accumulate, SOPs go stale, and vendor audits fall behind.
And when an FDA inspection happens, it’s your ClinOps people who are the ones pulled into the war room to gather documentation because there’s nobody else to do it.
An embedded Clinical QA or GCP QA consultant owns quality oversight for clinical activities:
SOP development
Inspection readiness
GCP compliance monitoring
Vendor/site audit programs
CAPA management for clinical findings
We’ve placed these consultants at a range of sponsors, from staff augmentation at larger companies to full-time Senior Manager of GCP Quality roles at mid-size sponsors. One extended Clinical QA support engagement ran long because the sponsor needed sustained quality coverage across multiple programs.
We’ve also done more targeted engagements: get inspection-ready for an upcoming FDA visit, stand up a vendor audit program, or remediate GCP compliance findings from a previous inspection. The practical value for Clinical Operations is that quality issues get caught upstream. Your ClinOps team stays focused on trial execution instead of getting pulled into compliance fire drills.
The common thread here
All six of these models solve the same basic problem: a sponsor needs Clinical Operations capacity and doesn’t have it internally. The role is unfilled, the workload is temporary, or the required expertise is too specialized to justify a permanent hire.
But there’s a bigger strategic point underneath the tactical one. With more sponsors moving away from pure CRO outsourcing and toward hybrid models, the question isn’t whether to insource or outsource. It’s which functions benefit from having domain expertise sitting inside your organization, operating under your systems and SOPs, retaining institutional knowledge that stays with you rather than walking out the door with a CRO’s personnel changes.
If you don’t have someone who knows enough about the domain on your side of those relationships, it’s very likely you’ll end up spending more and getting less.
If you’re sitting on an open Clinical Operations role that’s been vacant for 60+ days, or if you need capacity you can’t justify as a full-time headcount, it’s worth considering whether one of these models fits your situation.
Learn more and reach out to our team if you want to talk through it.
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