PCG Clinical Services is attracting repeat US customers due to our flexible and experienced staff and expertise as Viedoc master users, all of which leads to shortened study start-up. The EDC team analyzes the study protocol and identifies the optimal setup solution while reusing any aspects of the eCRF set-up from their vast library of previous trials. This shortens the timeframe to “go-live” and in PCG´s case, a normal set-up timeframe of Viedoc (eCRF) is only 6-8 weeks depending on the trial complexity and resourcing.
Important challenges for any eCRF solution:
The regulatory approval time in the US is rather short, compared to many other parts of the world. Therefore, to complete study start-up and start running as soon as possible after all applicable regulatory and ethical approvals have been obtained is a critical success factor for any clinical trial.
In addition, potential amendments often require the e-CRF to be updated. Having flexibility in an EDC, along with a quick turnaround, is crucial to ensure a trial isn’t delayed right out of the gates.
PCG Clinical Services solution
Viedoc is PCG’s preferred eCRF system, built with the end-user in mind. The standard set-up time for Viedoc is 6-8 weeks from when the original protocol is available. eCRF updates after approval of an amendment can be live within 2-3 weeks.
PCG offers the benefits of a large CRO in terms of EDC expertise and biometrics while retaining the benefits of an agile and focused small CRO. More importantly, PCG offers a substantial cost saving when building Viedoc and due to our expertise and knowledge, quality is never compromised.
PCG gives you everything you need through Viedoc, especially the high quality and regulatory compliance along with exceptional flexibility. As a testament, PCG and Viedoc have been successfully audited 200+ times!
Benefits of PCG’s solution
PCG Clinical Services personnel has performed 370+ eCRF set-ups! Each study is a customised set-up based on the needs of the eCRF with the best solution for the protocol and for the sites that enter data. More importantly, all data can be viewed through customized graphs and tables in Viedoc or extracted in Excel, PDF, CSV, or CDISC format. The goal is to never set-up obstacles between you and your data.
We practice what we preach, our data management and biostatistical departments use Viedoc in their daily life, which leads to a more efficient review of data for your study.
Why should a US company work with PCG, a Swedish company?
Sweden is one of the best English-speaking countries in the world with close to 90% of the population speaking fluent English. In addition, Sweden is one of the top countries in the Life Science community and in innovation. Not only that but Swedish companies are known for their high standard in work ethic, gender equality, and ecological sustainability.
Other important reasons particularly focused on our company, and services, we offer the following benefits:
With Viedoc you don’t have to worry about platform availability, maintenance and backups. A web browser is all that’s required to access the full functionality of Viedoc. The Viedoc platform consists of several applications and thousands of features that can be turned on or off in a specific trial. With this rich variety of possibilities, the platform is ready to take on any kind of trial in any phase. Health economic analysis can be performed through build in health economic modeling.
ViedocMe™is an ePRO module (electronic patient reported outcomes) that lets your subjects report data via their smart-phones, tablets, or computer – ViedocMe runs on any device with a browser. You can setup automatic reminders via SMS or e-mail to make sure you collect the relevant data within the designated time frame. ViedocMe is eliminating both the need for data entry by site staff and potential transcription errors, by collecting data directly from the source.
Viedoc is CDISC compliant which makes dataset (e.g SDTM) programming and creation very efficient.
Contact us to learn more. We can’t wait to exceed your expectations!