Clinical Research: Phase 1 - Phase 4

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 setting sponsors up for success with a single contact throughout the start-up process, from country/site identification and regulatory, IRB, and EC submissions to site activation.

That way, our customers 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 absence of careful planning.

Once the study is awarded, it becomes the responsibility of a dedicated Project Launch Manager whose sole focus is effective and efficient start-up, laying the foundation for successful execution. All these PLMs do is start-up, and here’s why: Clinical trials typically last for years, and staffers 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 for sites to negotiate nuances of the clinical trial agreement.
  • First things first. You should have a final protocol synopsis in place before initiating site identification. It will help you identify and qualify sites that have the necessary resources and experience. Recruiting effective sites and high-performing investigators helps ensure rapid recruitment and patient retention.
  • 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 we have moved toward a centralized approach for trial consistency and management, we believe in utilizing the local expertise on the ground as a way of maximizing success in each country.
  • 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.

For more information about developing a study start-up plan that meets your needs – and exceeds your expectations – contact our team today.