Rethinking Clinical Operations for Sustainable Growth: Best Practices from Biotech and Big Pharma Leaders

Imagine you’re the head of clin ops at a fledging biotech. Today you’re working with one molecule and one study, envisioning the day you'll run multiple studies worldwide across many therapeutic areas. How do you invest wisely in your clinical operations so that you can successfully execute today’s study while also scaling for tomorrow?

On our Winter Games Torch Relay panel at SCOPE 2026, clin ops leaders from four pharma companies large and small shared strategies for “carrying the torch” from a single study to an enterprise portfolio.

First, let’s introduce the torchbearers on our panel:

• Jay Russak, Invivyd
• Tricia Buchheit, Alnylam Therapeutics
• Jenn Curry, Biogen
• Madi Geday, Teva Pharmaceuticals

Now let’s look at what they say is crucial to scaling clinical operations at every stage. Starting with a single phase 2 study, they explained what's highest priority as new studies, locations, and therapeutic areas are added to a sponsor’s portfolio.

Single phase 2 study

A small biotech running a single phase 2 study will benefit the most from forecasting accurately and using those forecasts to outsource wisely.

At this stage, accurate forecasting is essential, requiring more than straight line estimates based on more than a patients per site/per month figure. How many sites are needed for the study? What are the regulatory timelines? What is the site ready curve? What about screen failures?

However, with such a small team, you’ll need to outsource quite a bit. Different CROs may provide wildly differing forecasts, without using the right assumptions. It’s important to have a tool that shows the probability of success with different variables, accounting for things like staggered site setup, variable enrollment rates, regulatory timelines, screen failures, and unexpected roadblocks.

It’s important to get the base case and startup set up correctly before handing things off.

Three phase 3 studies (two global)

With a few more studies and multiple countries in the mix, reliable forecasting remains a high priority. But now scaling patient recruitment efforts becomes even more critical. This means:

• Streamlining technology implementation
• Allowing for more flexibility in outreach tactics
• Gathering the right metrics and showing ROI

Here it’s important to recognize the unique needs of different indications, regions, and sites. You’ll need the ability to be flexible, while establishing standardized processes. Ideally, you can offer flexibility in recruitment strategies and tactics, but maintain a uniform recruitment journey that scales quickly and affordably while providing ROI on everything.

Five studies (three global), two TAs

Now you’re cooking...you’ve added a new therapeutic area, and you’re running five studies while expanding even more across the globe. You’re also working with many more sites.

At this point, you may have already worked with multiple recruitment vendors, with the desire to expand. This creates inefficiencies for both you as the sponsor and for your sites. It's time to invest in tech that offers a scalable trial finder for your enterprise, and streamlines individual study recruitment, while maintaining visibility and control.

Streamlining your site activation and training is also mission critical now. With many different trials going on and multiple TAs, it’s necessary to offer well-organized, non-redundant, role-based training. Document management will also be more difficult at this stage—automated TMF is more important now than ever.

As a member of the SCRS Cut25 Training Initiative, ProofPilot offers the most site friendly training technology, incorporating all of the Cut25 principles and recommendations.

Enterprise portfolio

You’ve made it to the big leagues: multiple TAs, thousands of sites, and a whole lot of chaos. But it’s controllable chaos!

To be successful, you need to control costs and manage accountability across many more capabilities. This requires a planning, visibility, and control framework that enables all studies to succeed consistently and predictably.

Best practices for this stage include:

• Establishing clear roles and responsibilities
• Employing adaptive, real-time forecasting
• Swapping out spreadsheets for automated tools and processes
• Prioritizing the most efficient site training model
• Optimizing recruitment with an enterprise trial finder, registries, and self-serve study-level technology
• Offering a consistent site experience to simplify complex operations at the site

Ready for a smarter way to scale?

Whether you’re running one study or 20, with the right tech and tactics in place, you’ll be able to execute simple, predictable trials while maximizing your ROI.

No matter where you are on the route toward an enterprise portfolio, let us help you set up your operations to scale successfully. Schedule a demo today.