Study Start-Up: Why You Really Need to Get This Right

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating.

That’s why we created a department that consolidates all the expertise needed to get trials off on the right foot. The underlying goal is to simplify by doing a lot of advance work and by giving sponsors a single CRO interface who takes on all the worries — from protocol design to regulatory affairs, from site selection to ethics.

That way, our sponsors can focus more on science and less on … everything else.

The process actually starts before the study is even awarded, at the RFP stage. There’s no better time to hone our understanding of what’s important to the sponsor: first site initiated, first patient in, or whichever other goal is most relevant. Assessing large amounts of data at the pre-award stage is vital to putting the study on the right path and is indispensable in developing the contractual agreement post-award.

It’s a lot of effort on our investment dime, but the payoff can be considerable in a smoother study launch without the false starts and missteps that often result from the absence of careful planning.

Once the study is awarded, it becomes the responsibility of a dedicated Project Launch Manager and a focused start-up team whose sole focus is an effective and efficient start-up, laying the foundation for successful execution. All these project launch managers do is study start-up, and here’s why: Clinical trials typically last for years, and team members who stay aboard a trial from start to finish lack the opportunity to develop the highly specific skills and disciplines that ensure an effective launch.

Having an itinerant launch crew that moves from trial to trial guarantees that every study gets our best start-up expertise.

Here are some other start-up recommendations we offer to current and prospective customers:

• Set realistic timelines. Sponsors often have rigid timing for study milestones, and the clock starts as soon as the CRO contract is signed. But start-up is time-consuming, labor-intensive, and expensive, so it helps to establish realistic expectations — for example, allocating time to identify the right sites or time for sites to negotiate nuances of the clinical trial agreement is vital for a right timeline estimation.

• Start with the end in mind. A final protocol will help you identify and qualify sites that have the necessary resources and experience; however, we know that time is money and sometimes requires alternative thinking; we can expedite site identification based on a protocol synopsis to work things in parallel. Recruiting effective sites and high-performing investigators helps ensure rapid recruitment and patient retention.

• Leave no stone unturned. Use all available resources to identify sites. Sponsor and CRO site databases are useful in cultivating and maintaining long-term relationships with high-performing sites. But if you’re searching for new sites and/or investigators within a specific geographic area or therapeutic area, you may need to look outside of your existing database.

• Is everyone on board? In global studies, it’s critical to ensure that the study protocol is approved by the necessary regulatory authorities and ethics committees in every country where the study will be conducted. While other CROs are moving toward study start-up hubs, we still use a localized start-up approach with separate start-up groups on the ground in each country. A team of country regulatory experts led by a regulatory start-up lead will oversee and perform submissions adding the country-specific knowledge to make the process smoother.

• Conduct a pre-study visit. It will help ensure that the objectives and expectations of the sponsor and CRO are aligned with those of the investigative site.

• Monitor enrollment progress. Investigators often overestimate the number of patients they see with a certain condition, and that can hurt your feasibility study and recruitment projections. If you are falling behind on enrollment, be prepared to put significant resources into marketing the study to investigators, sites, and eligible study participants.

At Premier Research, our people are what make the difference when it comes to ensuring every piece falls into place. From identifying the sites to compiling the core clinical regulatory packages, a dedicated study start-up team supports your effective project launch. Learn more about our integrated, technology-enabled approach to study start-up here.