Introduction
We all know managing studies are challenging. However, how much thought do you give to improving the startup phase, where much of the critical groundwork is being laid? If you’re like most folks we’ve spoken to, you’ve accepted that the study startup is done through, phone, fax, email and excel spreadsheets. Too complex! Too manual! Too inefficient!
The study startup phase, which includes investigator enrollment and submission of new investigator packages, is a time-consuming component of the clinical study process. The study startup phase is burdened by a manual and heavily paper-based process that involves a legacy IT infrastructure, which is ripe for some optimization.
The Clinical Study Startup Series
This series will focus on this key area of the clinical trial process – study startup – and shows ways on how to optimize each of the steps to gain a significant competitive advantage in new drug product development. We’ve spent the past 6 months, interviewing sponsors, CROs and sites to determine what goes on in the study startup phase and ways the process can be improved.
Here, we’ve summarized the 10 key steps we identified that sponsors take to select sites and activate them for a clinical study. Over the coming weeks we will break down each of these steps and provide you with our key learnings. The goal is to initiate a dialogue with the broader clinical research community on how to improve how things are done.
Coming Soon!
The first part of our series will be published on April 21 with tips and suggestions on what you should do when identifying sites. Subscribe to the Chromosome and get updated when new steps are published!
{ 9 comments… read them below or add one }
Dr Jung,
This is a very good initiative. I will be very pleased if you need my inputs on the current status of clinical research in India
Hello Dr. Janakirman,
Thank you for your comments. We always welcome perspectives from other regions and look forward to hearing your thoughts. Feel free to correspond with us via esam@gobalto.com.
- Jae
PS – I am not a doctor. Although my mother wished I was one!
I think this would be a very valuable series. I’d be happy to promote within my LinkedIn groups and in the knowledge center on our site. Please let me know your thoughts.
KWW Director Global Marketing ClinPlus
I would like to talk with you on study start-up. I am currently lookinf for clincial trials for Urology and Neruology in Fredricksburg, Va.
Thanks
Hi Larry,
Thanks for commenting. Try checking out http://www.clinicalconnection.com.
Hope this helps!
Jae,
As someone working in outsourcing and clinical research services I am really enjoying the series. I’m sharing it with my co-workers as we speak. Keep up the great work. Thank you!
Kindly,
Jared
Jared,
Appreciate the kind words and am glad to hear the series are helpful.
Best,
Jae
Dear Jae Chung,
today read the 8th step IM, I remembered my first IM & enjoyed those moments once again.This is a wonderful series & I learned & enjoyed it a lot.
Great article. Are all 10 steps available as one article and if yes, can someone send me the link. Abdul