Get your study eCRF running in only a couple of weeks
Case study summary:
LINK Medical is attracting repeat US customers due to our flexible, experienced staff and expertise as Viedoc Master Users, all of which contribute to a shortened study start-up. Our electronic data capture (EDC) team has been involved with Viedoc, our preferred EDC system since its inception and LINK Medical has now delivered over 350 studies on the platform. Our expert team analyzes study protocols and identifies the optimal setup solution within two weeks. We can also draw from our vast library of previous trials and leverage many aspects of previous electronic case report form (eCRF) set-ups. This shortens the timeframe to “go-live” and in LINK Medical´s case, a normal timeframe for setting-up Viedoc (eCRF) is only 6-8 weeks depending on trial complexity and resourcing.
1. Important challenges for any eCRF solution:
The regulatory approval time in the US is relatively short compared to many other parts of the world. Therefore, a critical success factor for any clinical trial is to complete a study start-up and start running as soon as possible after all applicable regulatory and ethical approvals have been obtained.
In addition, potential amendments often require the eCRF 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.
Difficult, expensive, and inflexible eCRF solutions are common throughout the industry, but LINK Medical can provide a more cost-effective and flexible solution.
2. LINK Medical’s Solution
Viedoc is LINK Medical’s preferred eCRF system, and it is 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. In addition, eCRF updates after approval of an amendment can be live within 2-3 weeks.
LINK Medical can offer substantial cost savings because of the smart efficiencies built into Viedoc. Our expert knowledge of the system – along with the experience of our study design team – ensure that quality is never compromised. Our expert team provides everything you need: high quality, guaranteed regulatory compliance, and an exceptionally flexible eCRF. In addition, we are audited by our customers several times a year and the outcomes further contribute to maintaining our high-quality standards.
Benefits of LINK Medical’s solution
Each study is a customised set-up, which we develop by understanding the unique needs of your eCRF. Our expert team will help you find the best solution for your protocol and for the sites that enter the data. More importantly, all data collected during a study can be viewed through customized graphs and tables in Viedoc, or extracted in Excel, PDF, CSV, or CDISC format. We ensure that all obstacles are removed between you and your data.
We practice what we preach, and our data management and biostatistical departments, therefore, use Viedoc in their daily life, which leads to efficient reviews of data for your study.
Benefits of working with a Scandinavian company:
Scandinavian countries have several factors that create an optimal environment for carrying out your clinical studies:
- Scandinavia can essentially be viewed as an English-speaking region, with close to 90% of the population speaking fluent English.
- Scandinavian countries have a highly educated and engaged population with strong traditions in life sciences.
- Scandinavian countries are renowned for their expertise in life science, data management and statistics.
Top benefits of working with LINK Medical:
- We are a full-service CRO with experienced experts in all key areas of clinical development.
- We are Master Viedoc Users with in-depth knowledge of the sophisticated EDC system to shortened eCRF set-up.
- We have decades of biometrics experience, along with a strong and proven track record.
Contact me to learn how we can support your clinical development
Pontus Lamberg,
Business Development Manager
pontus.lamberg@linkmedical.eu
