Agility Clinical is a fast growing consulting and contract research organization that works primarily with virtual-to-small biopharmaceutical and medical device companies that often specialize in rare disease and orphan drug development. They provide full clinical trial services from IND submission, orphan drug application, and , study design through regulatory submission for marketing approval. As an adopter of the latest technologies, they started using Projecis shortly after Agility Clinical launched in 2012.
"We use Projecis on full scope projects to share the calendars and to monitor our staff in terms of scheduled time off, which really helps us manage our human resources. We can post minutes from a meeting and ask everyone who wasn’t there to read through them, comment on them, to make sure that the whole team stays informed and on the same page. The system also provides an excellent audit trail to ensure that team members and clients are staying on track with review schedules."
All clinical trials involve a significant need for secure, controlled access to information. "We were one of Projecis' early clients and they were very responsive to our growing needs. For example, they created a way for us to share Standard Operating Procedures with clients who wanted to review them, but in a way that wouldn’t allow them to be downloaded or printed. The Projecis team is incredibly responsive and created a solution that is flexible and adaptable to our needs."
The feature-rich document sharing capabilities have become an essential part of Agility’s our project life cycle. “We use Projecis to give our clients access to documents for customized review periods with , specific date ranges, which is very helpful. We create a secure project ‘room’ within Projecis where we can share and collaborate with our clients. They can tell us what they want to see and we can pull it from the Trial Master File, upload it to Projecis, and share it from there. It’s convenient, protects the documents, and is accessible to the team members from any location with access to the internet. Projecis is very intuitive, allows for a clear file structure, and offers a robust search capability, which makes it very easy for clients and our internal team members to navigate through the project documentation.”
“Projecis is also an important part of our communication platform with our international clients based in Europe and/or Sub-Saharan Africa. Emailing large files across several internet access points is not safe or convenient. Additionally, the standard paper size in Europe and Africa is not the same as the US, so sending a hard-copy binder to a site in Africa or Europe would not only be expensive, but it just wouldn’t be practical for our sites or clients. Instead, we can upload the required documents into Projecis and then our team members can access and print them on their end. This kind of convenience and customer service lowered costs for our clients and created efficiencies.”
Agility specializes in orphan/rare disease research and often its clients have tight operating budgets. “Projecis is an affordable way for us to work together and support our clients without an expensive electronic TMF solution or Clinical Trial Management System (CTMS),” says Clark. “In addition, many of our study sites are spread out geographically, so for just a small fee, we can have Projecis seats for whoever needs to be involved. We have quite a few users, and Projecis has consistently been a dependable, easy-to-use tool to help us manage our projects, knowledge and resources.”
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