Why Imperial
- Over 10 years experience working with study teams developing tools that can help clinical teams and sites successfully implement eClinical strategies.
- Firm understanding of ICH/GCP and the types of material that will support site operations when implementing process changing technology
- Leading provider of solutions that assist sponsors and CROs in meeting their regulatory requirements when locking and closing EDC studies
As the industry looks to technology to accelerate the drug development process, sponsors and study teams are faced with new challenges on how best to support sites and the operational changes that eClinical solutions require. Imperial has been providing solutions that address site optimization challenges for over 40 years. It still comes down to understanding the challenge, developing a well reasoned and informed solution, and then working with all stakeholders to implement the plan. Our eClinical solutions include:
- Site initiation toolkits that help with the implementation of an EDC platform
- CD’s of the eCRF subject data provided at study close that needs to be archived with the site study binder to support regulatory audit requirements
- Designed source documentation to capture study data prior to entry in the EDC system
Regardless of the need, Imperial is ready to assist in supporting the successful role out of your eClinical strategies.
