Clinical.Net 3.0

The OPIS Clinical IT team just released version 3.0 of the Clinical.Net Study portal.

 

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In an exclusive interview, Communication and Information Technology Manager Fabio Renna and Head of Systems Development and Programming, Salvatore Scarciglia talk about the challenges they faced in developing the new version.

INTERVIEWER:
IT developers and System Analysts face increasing demand from Sponsors to satisfy the need to comply with stricter data protection regulations. Was this one of the reasons to upgrade version 2.0?

FABIO RENNA:
Data protection forms an intrinsic part of clinical software development and our Clinical.Net has been developed to satisfy this very important need from the start. The fact that we closely collaborate with the OPIS Medical Department as well as the Quality Department, allows us to immediately design in compliance with the latest security and data protection regulations (e.g. FDA 21 CFR part 11).

INTERVIEWER:
So, what were the main reasons for the upgrade then?

SALVATORE SCARCIGLIA:
The fact that data need to be available anywhere, on any device and at any time is something that has become standard practice in most environments today and our web-based software was developed to facilitate data access. For a clinical software developer though, proper importation of data and integration with other systems such as those of Sponsors or central laboratories, are fundamental aspects that need consideration and I would say that this was the main reason to upgrade our 2.0 version. The new version is highly customizable and foresees full integration with other validated systems…even medical devices and wearable devices.

FABIO RENNA:
Furthermore, new cancer therapies and NGS (Next Generation Sequencing) technologies are changing clinical study design. Studies ask for more data, more frequently with constant screening, e-Data Capture and e-Imaging. Our new version is able to interface with imaging providers and central laboratories more easily. Another important aspect is the elaboration of data that needs to be immediate. Our new eSAE and protocol deviation modules facilitate this process significantly.

INTERVIEWER:
How would sponsors receive data and how easy is it to access these data?

FABIO RENNA:
Elaborated data is extractable as reports either reporting status or showing information graphically. Sponsors can access all kinds of data even raw data from server to SAS if needed.

INTERVIEWER:
Do you have a system for alerts and effective internal communication between trial stakeholders?

SALVATORE SCARCIGLIA:
Most definitely yes. Feedback and alerts are embedded into the system and any alerts e.g. about new randomization, SAE or clinical worsening are communicated via email. All communication goes through the server as to avoid the necessity of any other ways of communication.

FABIO RENNA:
Another advantage of this embedded IWRS is that it allows for online randomization, and proper drug supply management…oh…and obviously also the possibility to interface with standard IVRS systems.

INTERVIEWER:
This brings me to ePro solutions? Is that something you considered?

SALVATORE SCARCIGLIA:
If you mean solutions with possibilities to provide patients with devices such as smartphones or tablets, YES. OPIS is able to provide such solutions, even BYOD solutions but strictly in accordance with Sponsor specifications and regulations regarding authenticity and safety of data.

FABIO RENNA:
We like to keep a close check on trends and latest technologies in our industry. By attending congresses and speaking to opinion leaders in the field, we have a pretty good idea of what is out there and in which direction innovation is going. The important thing though, is to adopt these advancements with careful consideration and thorough understanding of the clinical research industry.

INTERVIEWER:
What were the biggest challenges you faced with this new version?

FABIO RENNA:
For us, the challenge was to improve user experience. We continuously strive to make our software more user-friendly. Customization and personalization to satisfy clients’ needs is another challenge we constantly need to face but I have to say that a competent and creative team makes all the difference!

INTERVIEWER:
The strength of OPIS lies in the fact that your team works in close collaboration with the OPIS biometric and clinical operations team. Can you tell me something about how you operate?

FABIO RENNA:
I think we can define ourselves as a Clinical IT team. This implies that all of our team have knowledge and experience in the clinical research field. We work closely with our Medical Director, Biometrics Department and Quality Department and this is a great advantage for clients.

SALVATORE SCARCIGLIA:
We can truly streamline the process of clinical software development because we get direct contribution from these departments about user requirements, eCRF design, functionality specifications and validation requirements.

FABIO RENNA:
To develop software in-house ensures flexibility and tailored solutions which can be updated in accordance with the latest trends in clinical research. No involvement from external software suppliers is necessary. The difference between having a suit specially made for you by a qualified tailor or buying your suit in a shop and having to get someone shorten the trousers before you can wear them.

 

For more information about OPIS e-Clinical services please contact office@opiseurope.com