The standard Research Online product is already an extremely versatile and highly GCP-compliant EDC system. But it gets even better, because there is also an extensive range of integration capabilities that match perfectly with the various applications within Research Online.
For instance, the logistics support add-on feature is the ideal tool for providing flexible and reliable support, starting with the recruitment and inclusion process, right through to the conclusion of gathering all the data involved in the study.
Similarly, the randomisation add-on provides the best possible tool for randomising clinical research participants in a flexible and secure way that is easy to use.
With the sample tracking add-on you will have complete control on your sample collection.
These modules also make it possible for Research Online to be used in highly complex, large-scale studies.
Add-on for logistical support
Many patient-related, administrative procedures are involved when conducting clinical research programs. All of this paperwork and red tape take up a huge amount of time, often making it a challenge to maintain a clear overview of the work going on. Of course, when it comes to clinical studies, all patient-related procedures have to be handled carefully and carried out in good time. This makes the Research Online add-on for logistical support an essential tool for enabling any clinical study to run smoothly and for the research to be conducted in accordance with GCP guidelines and privacy legislation.
|Anchor relationships of participants within families or other relations|
|Include participants based on in- and exclusion criteria|
|Avoid double inclusions by checking the presence of participants at other sites|
|Plan appointments for Informed Consent interviews or study visits|
|Communicate by e-mail or letter with study participants, doctors, pharmacists or other individuals involved in the study|
|Send out online questionnaires and reminders to study participants|
Add-on for randomisation
The Research Online add-on feature for randomisation is a sophisticated, web-based tool by which participants in clinical research programs can be randomised according to the study requirements. Secure, role-based access to the web tool, combined with the audit trail, ensures that the randomisation itself is conducted totally in accordance with GCP guidelines.
|Stratification possibilities on site level and other factors|
|Fixed and random block-size randomisation |
|Proportional, probability and best minimisation |
|Full compliant for trials with adaptive design|
Add-on for sample tracking
The Research Online add-on feature for sample tracking is an ideal tool in large complex clinical studies when samples are collected and stored at various locations.
|Overview, location and status of all collected samples|
|Supports the registration, sending, receiving and distribution of samples from local sites to central labs and analyze labs|