Sharp project managers across the US, UK, and Europe on the prep work that makes or breaks your FPI date
Michael MacNeir, VP, Business Development, Sharp
When a clinical trial timeline slips, the delay is rarely where the sponsor expects it. Ask what stands between a study and its first-patient-in (FPI) date, and many will picture the physical work of filling, labeling, and boxing the drug, but that execution stage can happen quite quickly.
Time is lost much earlier, in the weeks and months of preparation that determine whether packaging can even begin. Legal contracts can take longer to sign than anyone plans for, label text can be more complex than expected, regulatory approvals can stall progress, and components can be subject to unanticipated lead times.
The good news is that these hold-ups are also the most avoidable if you know they’re coming. To map out where sponsors most often lose time, and how to stay ahead of it, I spoke with four of Sharp’s clinical project managers: Amanda Gaba and Madison Jasinski in the US, Lee-Anne Taylor in the UK, and Robin Mebius in the Netherlands. Between them, they’ve managed over 160 trials across more than 40 years of supporting sponsors on both sides of the Atlantic.
What good preparation looks like
Michael: What would you consider the gold-standard timeline for clinical trial preparation?
Amanda: There isn’t really a one-size-fits-all timeline for clinical trial preparation because every study is different. The timeline is influenced by factors such as the trial phase, therapeutic area and geographic scope.
A Phase I study might have 20-100 participants across fewer sites, making for a simpler startup than a Phase III study with maybe 1,000-30,000 participants and a global scale. Global trials often have additional hurdles that elongate the preparation phase, such as country-specific regulations, translation requirements, and import/export permits. A lot happens before the product is ready for labeling and final patient use. Teams may still be finalizing contracts, sourcing drug products and packaging components, completing analytical testing, progressing manufacturing, and carrying out any required primary packaging steps, such as blistering or bottling. All of these activities can have an impact on timelines.
Then, in terms of therapeutic areas, indications such as oncology and rare diseases may have more complex protocols and stricter criteria, which add complexity and can extend timelines.
Michael: Within that window, which action items do sponsors need to ensure are completed?
Lee-Anne: They need to complete contract negotiations, accounting for them in the overall timeline. Sponsors often negotiate with the manufacturer, IMP supplier, and CRO in parallel, so there is more than one contract to account for. In my experience, sponsors don’t always appreciate just how impactful contract negotiations can be on timelines, so my advice is simple: build that time in from the outset. They should also provide the final protocol at kickoff, with pack design agreed early; align IRT specifications with that pack design; provide label text in good time; and order drug and packaging components, with contingency time for unforeseen delays built in.
Madison: I agree that contracts are consistently underestimated, and by the time one is in place, you’ve often lost a couple of weeks. Sponsors should start those conversations early. More broadly, early, proactive planning and aligning all stakeholders from the outset are critical. Ideally, engagement with drug-product and packaging manufacturers, regulatory strategy, and supply planning will all happen in parallel rather than one after another. That’s what lets teams identify risks and other dependencies early. Starting these conversations too late or working in silos compresses the timeline later.
Early, proactive planning and aligning all stakeholders from the outset are critical.
— Madison Jasinski
The biggest causes of timeline delays
Michael: Besides contracts, what tends to eat into the trial timeline most?
Lee-Anne: Changes in scope are also a big source of delays. A sponsor has an idea of how something will work, but in the real world, it doesn’t quite work out that way. I don’t think sponsors always appreciate how much a seemingly minor change can ripple through a timeline.
The other is label text. If the provisional text arrives very late, or the protocol is finalized, changed, or shared late, it delays the final approved label text and has an outsized impact.
Robin: The one thing I’d single out is the booklet label. Sponsors underestimate the design process at the best of times, and if translation is needed, it becomes genuinely lengthy. It’s one of the most common things sponsors don’t leave enough time for.
Changes in scope are also a big source of delays. A sponsor has an idea of how something will work, but in the real world, it doesn’t quite work out that way.
— Lee-Anne Taylor
Michael: In today’s climate, what are the risks around vendor lead times, and what steps can sponsors take to mitigate them?
Lee-Anne: We are seeing some real challenges right now in the UK—material shortages, customs delays, varying lead times, and price increases. Those challenges are manageable, but it depends on having strong relationships with your approved vendors so they can keep you updated on any challenges, and so you can give them as much lead time as possible when ordering.
Amanda: I agree, regular communication with vendors allows you to plan proactively, and creates an established working relationship between the teams that makes it easier to expedite requests when you’re working within a time-critical timeline.
Components are typically ordered on a project-specific basis, so their delivery dates are critical for scheduling. If lead times run long, it delays the start of packaging and ripples through the whole timeline. The lead times are ultimately outside our control, but close monitoring means we can mitigate early.
Production and labeling complexity
Michael: What are the challenges or misconceptions around production and labeling?
Madison: Probably the most common thing we hear from sponsors is, “This is a simple labeling operation, why does it take so long?” While individual steps may look simple, people often overlook how interdependent everything is—procurement, components, label text. You can’t simply move one forward without the others, which is what makes it so complex.
Lee-Anne: People imagine production is the time-consuming part, when the complexity is really in the setup. Once it’s in production, it’s much simpler.
Amanda: And remember, we’re working with drugs for patients. So, even if the end product is a single labeled bottle, there are internal procedures and cGMP processes we must follow to ensure patient safety that add time and complexity.
Labeling, in particular, is often the kickoff point for the entire project, provided we already have an approved quote in place. Pending label text can put the entire project on hold because many downstream activities depend on it. Without approved text, we can’t begin proofing, printing, or moving toward producing the finished product, so this is where many sponsors can find themselves stuck.
We’re working with drugs for patients. So, even if the end product is a single labeled bottle, there are internal procedures and cGMP processes we must follow to ensure patient safety that add time and complexity.
— Amanda Gaba
Michael: Labeling comes up again and again. What are the problems you’re commonly seeing there?
Lee-Anne: Usually, label text is already submitted to the regulatory authority by the time it reaches our team, but sanity checks can sometimes get missed. For example, on small items, a sponsor might expect a novel’s worth of text to fit on a blister or a tiny vial. Most often, though, it’s about checking the label text against the protocol to ensure it’s fit for what they’re actually trying to achieve, and against regulations, so that any risks are flagged.
Amanda: Our spot checks tend to identify small text errors, like wording that could unblind a double-blind study. Stated strength or dosage is another common one: we might receive a drug at one strength, and the text says another, so we’ll flag it. The errors are easily missed, so it’s essential to perform a character-by-character verification and cross-check every piece of variable data against the printed label.
Beyond the text, there’s also the label itself. It needs to be the right label size for the volume of text at a readable font, and the right stock to ensure adhesion under the required conditions—frozen, dry ice, and refrigerated all behave differently.
Michael: What are the considerations for IRT/RTSM compatibility?
Amanda: The kit list file needs to match the format and fields the IRT expects, include the data (kit numbers, lot, expiry, treatment assignments), be complete and accurate, and have kit numbers randomized to maintain blinding. A manufacturer can confirm a list is structurally sound and supports blinding, but overall accountability for IRT setup, testing, and go-live rests with the sponsor, IRT manager, and drug supply manager.
QA and QP release timelines
Michael: What’s needed to effectively plan QA and QP release timelines?
Lee-Anne: Release timelines need to be built into project plans from the start. In the UK, sponsors have to wait for regulatory approval before progressing to QP release, so it’s best to plan against the sponsor’s best estimate of when they’ll submit and when they expect approval and add a buffer to be safe.
Madison: Agreed. Release and availability for shipment to the site are always the endpoints you’re protecting, so I build the plan backward from FPI and treat QA, QP, and logistics as a single integrated path.
Robin: You also need to have the QPs close to the project and participating as actual project members from the start. That way, they can signal potential risks as early as possible and keep QP readiness intact all the way to the end.
Michael: Where does regulatory approval fit into these timelines?
Robin: Most activities can be run in parallel with the regulatory submission, but, as touched on earlier, the one thing we can’t get past is that QP release needs the regulatory approval in place. The risk is the Request for Information, as an RFI can push the approval date out by months. If it’s the label text that’s questioned, that can drop us all the way back to updating the label designs. Early regulatory approval and consultation are essential—you don’t want labeled goods sitting ready for QP release, waiting only for approval.
Early regulatory approval and consultation are essential—you don’t want labeled goods sitting ready for QP release, waiting only for approval.
— Robin Mebius
Lee-Anne: That’s why we build contingency for late regulatory approval directly into the plan. It’s one of the things we keep closest tabs on with the customer. Where are they in the process, and has any change along the way triggered an update to a protocol or document?
What can PMs do to protect the FPI date?
Michael: Do you have any examples of a trial that was headed for a delay and how you turned it around?
Madison: A common one is a sponsor who needs a booklet for multiple countries on very short notice to meet their FPI date. Rather than wait for the full booklet, we ask: “Which country is first? Which do you have approval for?” Then we can start with a single-panel label covering just the priority country or two, meet the FPI date for those, and in parallel produce the rest-of-world booklet. It shortens the timeline without compromising anything.
Robin: I had a study where the drug product was delayed upstream, at another of the sponsor’s vendors, and so the FPI was in jeopardy. After assessing the options, we were able to lower the original packaging quantities and expedite some activities to still meet the FPI date.
Michael: Beyond the FPI date itself, what do you keep your eye on?
Robin: Drug product delivery is another area that requires close attention. When commercial drug procurement is required as part of the trial, lead times on those are often so tight that we could be awarded the project before the drug is even filled or released. When that happens, early planning is especially important to make sure the drug will be available for FPI.
Lee-Anne: I’d say the regulatory process and the financials. Budget tracking is more and more important to our customers, especially smaller companies and hospitals, who increasingly want our support in keeping an eye on spend as the project runs.
Madison: Logistics issues, such as ensuring the depots are set up and planning shipments, are critical. If the teams are in different countries, there’s added complexity due to differing holidays, which can impact the timeline.
How do good CDMO-sponsor relationships drive success
Michael: What does a strong sponsor relationship look like to you?
Madison: For me, it’s about being open, transparent, and realistic from the start. I always want to help sponsors move as quickly as possible, so I’m always looking for opportunities to keep things moving. For example, if a team has their label text but is still finalizing some of the variable information, we’ll focus on progressing the label work while we wait for that information. It’s really about having honest conversations, working through challenges together, and finding practical ways to maintain momentum.
Amanda: I think communication and collaboration are key. Customers sometimes preface a question with “this is silly, but—” and I always say there are no silly questions. Ask what you need to ask; we’re here to help you execute your project—let’s work together.
Ask what you need to ask; we’re here to help you execute your project—let’s work together.
— Amanda Gaba
Lee-Anne: For me, it starts at the kickoff meeting, ensuring we walk through everything that comes before FPI. The focus is always on the FPI date, and teams want to move ahead quickly, but there are a number of things that need to be completed first. Having those clear, open, realistic conversations at the start and building the relationship is what carries the project.
Robin: In the end, it’s a team effort. The CDMO needs to act quickly when the project calls for it, but responsiveness has to go both ways. When the CDMO needs a document or approval, the sponsor must return it promptly as well. When communication is smooth and the relationship is solid, going the extra mile no longer feels like effort at all.
Michael: What should a sponsor bring to that first conversation with a CDMO to set themselves up for success?
Amanda: In an ideal world, the sponsor would have the scope outlined up front. The questions on my mind will be: What are we labeling? Are you sending us the drug, or do we need to order it? When will the label text be available? What’s your FPI date? What are your quantities? If a sponsor has all of that information to share at the request-for-proposal stage, then the project is off to a really positive start.
Michael: To sum up, if a sponsor took just one thing from this conversation, what would each of you want it to be?
Lee-Anne: Share your protocol early and treat label-text approval as a genuine critical-path milestone.
Robin: Engage our QP experts as early as possible. Having their expertise early is what makes European release straightforward instead of daunting.
Amanda: Loop your CDMO in as early as possible, even before every detail is nailed down. The sooner they’re involved, the more options they can offer you.
Madison: Respect the process. It’s extensive, and it’s there for a reason—working within it, not around it, is what keeps your FPI date safe.
Listening to our four PMs, what comes through most clearly is that a missed FPI date is rarely one big failure. Instead, it’s an accumulation of small, often foreseeable, issues, addressed too late. To stay on track, sponsors need to start early, ask the “silly” questions, and build a strong partnership with their CDMO. With an experienced team to help you see around corners, a frantic countdown to FPI becomes a solid, reliable plan.
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About the authors
Michael MacNeir is Vice President of Business Development at Sharp Clinical, where he brings two decades of experience supporting pharma and biotech companies in finding solutions to complex global clinical trials. In his business development role, he is focused on helping sponsors optimize clinical supply chains through innovative packaging, labeling, distribution, storage, and supply management strategies. Michael is a frequent contributor to industry discussions on clinical supply resilience, risk management, patient-centric trial design, and the integration of technology-driven solutions that enhance trial performance and accelerate development timelines. He serves on the ISPE Steering Committee, ISP DTP Task team, and ISPE Digital Display Label (DDL) Task team.
Connect with Mike on LinkedIn.
Amanda Gaba is a Senior Project Manager, Clinical Supplies, at Sharp’s Bethlehem site, specializing in the coordination and execution of clinical packaging projects. She serves as the primary point of contact for clinical packaging initiatives, overseeing project planning and timelines while coordinating manufacturing, primary packaging, and secondary packaging operations. Amanda partners with cross-functional teams to drive project execution and support the successful delivery of clinical supply solutions.
Connect with Amanda on LinkedIn.
Lee-Anne Taylor is a project manager with Sharp Clinical in South Wales, where she brings 32 years of pharmaceutical industry experience spanning both clinical and commercial GMP operations to client projects. Lee-Anne has expertise across the full product lifecycle, with a strong foundation in supply chain management and CI. She focuses on balancing quality, timelines, cost, and regulatory compliance and management of complex project execution.
Connect with Lee-Anne on LinkedIn.
Madison Jasinski is a Project Manager, Clinical Supplies, who leads clinical packaging projects from initial planning through final execution. At Sharp’s Bethlehem site, Madison works closely with manufacturing teams, packaging operations, and cross-functional stakeholders to keep projects on track and ensure clinical trial supplies are delivered according to study requirements. Having managed more than 30 clinical trials throughout her career, Madison brings hands-on experience in coordinating timelines, navigating project complexities, and contributing to the successful execution of clinical studies.
Robin Mebius is a Project Manager, Clinical Supplies in the Netherlands, serving as the primary point of contact for clinical packaging projects. Robin coordinates primary packaging, and secondary packaging operations, manages cross-functional groups, and oversees project timeline planning and execution. With a strong foundation in commerce and a Bachelor of Commerce from NHL Stenden, Robin brings a structured, business-minded approach to keeping clinical packaging projects on track and delivering clinical supplies according to study requirements.
Connect with Robin on LinkedIn.
