10 Steps to Clinical Study Startup: Step 2 – How to send requests to investigative sites

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10 Steps to Clinical Study Startup: Step 2 – How to send requests to investigative sites
Introduction

Once sponsors have finished generating a short list of investigative sites, the next key activity is to contact the sites to assess whether the site has the required facilities and knowledgeable staff to successfully enroll patients and produce high-quality data for a clinical trial. Communication is typically initiated via email, telephone, or fax and are tracked using spreadsheets. Sounds simple right?

How requests are sent and tracked today

Imagine if a sponsor needs to engage 50 investigative sites to enroll patients for a Phase III trial. The sponsor would need to find the site’s contact information, send an email, fax or call, and then document/record each response received. As it turns out, most sponsors use spreadsheets and email folders to track all replies from the sites. Though some sponsors have developed in-house systems to tackle this activity in study startup, most companies don’t have the resources to build and implement an internal solution to facilitate this process.

The major drawback of using spreadsheets to manage and track responses from sites is the amount of manual work needed to keep them updated. A clinical research assistant/associate or clinical project manager needs to manually update the spreadsheet when responses from sites are received. This is not only very tedious but also leaves room for human error and mistakes.

Also, the follow-up procedure when dealing with sites can be cumbersome and lengthy. Spreadsheets work, however they require a great deal of customization and are not the ideal solution for such an important activity of managing and documenting responses from multiple investigative sites. This is a time-consuming activity and every day saved represents a significant amount of money and helps pharmaceutical companies ultimately deliver medicines to those in need faster. Sponsors need to activate sites as quickly as possible so that they can move on with all the other activities, which we’ll cover in future blog postings, so that they can reach the first-patient-in milestone much more quickly.

Sending requests to investigative sites can happen at any point in the clinical trial, not just the study startup phase. If enrollment for a clinical trial is falling behind and the sponsor needs to recruit sites quickly, the sponsor needs to perform the same steps, which adds even more complexity to the tracking procedures.

Caveat: These tasks and activities are performed in a variety of ways depending on the size of the Sponsor, phase of the trial, CRO involvement, however here we covered the general activities that sponsors perform that are general enough to cut across most organizations regardless of the specifics and details. Note that these activities are not necessarily performed in a step-wise fashion, but can happen in parallel with other tasks and at multiple points during study startup.

We would love to hear about your own experiences contacting and tracking communications with investigative sites. Let us know about the processes that have worked for you!

About the Authors

Allan Valmonte is the Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward.

Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com