In order to reach your goal of site activation within the shortest possible timeframe, our study start up team can simultaneously manage all the elements involved in this dynamic and ever-changing environment. As soon as you award us your clinical research program, we get to work. We can do everything in tandem: identify sites, prepare your patient engagement strategy, ensure all your documentation is regulatory ready at all times, finalize contracts and deal with protocol changes. We know that time and money are of the essence; that’s why we keep everything moving forward towards that all-important milestone of site activation, but at the same time ensure that we don’t compromise on quality, with all this complexity represented in an up to date and audit ready electronic Trial Masterfile.
Built on our strong regulatory and site relationships
INC Research strives to be a partner that is easy to do business with. As it becomes ever-more challenging to recruit the right patients for clinical trials, you need a CRO partner that has a deep knowledge of sites and regulators to help you achieve your goals. Our local experts are highly experienced and hold relationships with sites and regulators, which is paramount to getting approvals and contracts finalized to a site ready status and maintain the site through to close out.
Patient recruitment materials ready when you need them
It may be tempting to hold off until your final protocol is approved before getting to work on your patient recruitment campaign. But we know from experience that it’s vital to start on your recruitment materials right away. If – as is highly likely – there are any protocol amendments, we are ready for them, and can update everything swiftly. We also have local experts who understand the regional nuances when it comes to each country’s regulatory environment. We keep right up to date with any changes, too, to help keep the approval time to a minimum.
Documentation regulatory ready at all times
The INC Research study start up team processes vast numbers of TMF documents every year. We have a deep understanding of all the critical documentation you need for your clinical trial program and we will work to make sure it is regulatory ready. Although we’re ‘start up’ by name, we will in fact look after the entire regulatory life-cycle for you, maintaining all your documentation post-activation, operating through to close-out and archive.
Flexibility to changes in strategy
In Clinical trials change is inevitable, but within the start-up phase any change can have significant impact on the overall timelines and clinical trial deliverables. At INC Research, our experienced and local specialists implement these changes day to day. Your patient recruitment campaign could be affected by a required protocol amendment but this could in addition also affect site contracts and other patient facing materials. A thorough impact assessment is performed by the Site Activation Lead who then coordinates a multidisciplinary execution plan to achieve timely approval for all deliverables and to minimise the impact on overall trial timelines.
Partner with our experienced study start up team, and let our expertise and experience make the process swift and smooth for you.