Functionality and Usability Reduce Lead Times – the Reason CRO Aptus Clinical Chose Viedoc
Functionality, API integration capabilities and overall usability were the key criteria when Clinical Contract Research Organization Aptus Clinical chose Viedoc as their new EDC system last year.
“Viedoc was our first choice both when looking at the technical specification and more hands-on demonstrations. Now we can be completely self-sufficient in building our studies, which greatly reduces our lead times,” says Paul Blaney, Digital Health Lead at Aptus Clinical.
With a 20-year track record of delivering Phase I-III clinical trials, Paul Blaney knows what it takes to be successful in this area. He and his Aptus Clinical colleagues evaluated six different EDC systems in three phases, where Viedoc scored the highest in each phase.
“Naturally there’s always some growing problems to work out in the beginning but overall Viedoc fulfills all our needs, and we’re looking forward to working together for a long time to come.”
One of the deciding factors was Viedoc’s API integration capabilities.
“It’s vital for us to be able to seamlessly import and export XML and ODM files from our local systems and Viedoc’s functionality is excellent in that regard. Working with several separate systems is always a risk factor but with Viedoc’s API, it’s a non-issue.”
Aptus Clinical has now been up and running with Viedoc for some time, says Paul and summarizes: “The combination of high functionality and user-friendliness is what makes Viedoc stand out”.
About Aptus Clinical
Founded in 2013, Aptus Clinical is a specialist UK-based Clinical Contract Research Organization (CRO) with particular expertise in oncology, rare diseases and advanced, cell and gene therapies. Aptus Clinical is part of iMATCH, a Manchester-based consortium which is one of only three centres in the UK to be awarded funding by Innovate UK to coordinate scale-up of advanced therapies for a range of debilitating conditions.
Trust, service and reliability – Here’s why Oslo University Hospital signed a 10-year EDC deal
For Oslo University Hospital (OUH) it was a matter of trust, service and quality that helped them sign a 10-year deal with Viedoc.
– We’ve been working with Viedoc for four years, and it was an obvious choice to extend our partnership. Auditing and evaluating a new EDC system is an extensive process, especially for us as a public institution. Now we know that we’ll have access to a high-quality EDC system that we’re used to working with for a long time to come, says Cecilie Moe, Manager Data Management Section, OUH.
So far, OUH has performed over 50 studies with more than 1,300 participants in Viedoc. With the newly signed 10-year deal, OUH will continue using Viedoc for a long time to come.
– Viedoc exceeds all our needs when it comes to EDC and ePRO. The decision to use Viedoc was also a question of service and support – Customer service at Viedoc is easy to reach and quickly replies to our questions, feedback and suggestions. The people at Viedoc are just as important as the technical quality and are a major reason why we wanted to sign on for 10 more years.
A lot can happen in 10 years technology-wise, especially when it comes to Electronic Data Capturing, but OUH is confident Viedoc’s position will remain at the forefront of the EDC industry.
– We have firsthand experience of the high-quality development, upgrades and new features that Viedoc continuously implement into their system. and I expect them to further innovate the system for years to come.
Cecilie Moe sees no reason why the OUH – Viedoc partnership wouldn’t continue past the newly signed 10-year deal.
– Now that we’re sure we have an EDC system that works well for us now and over the long run, we can focus all our time and attention on the research.
About Oslo University Hospital
Oslo University Hospital carries out advanced patient treatment, research and trial treatments, gives advice and provides education on international levels. The hospital is Scandinavia’s largest and each year carries out more than 1.2 million patient treatments. Oslo University Hospital is responsible for approximately 50 percent of all medical and healthcare research conducted at Norwegian hospitals and is a significant role player within the education of a large variety of health care personnel.
GDPR – what happens with clinical research when Britain leaves the union?
On 25th May 2018 the General Data Protection Regulation (GDPR) came into effect within the EU – and soon Great Britain is leaving the union with what could be a “hard Brexit”.
Many of the responsibilities and obligations defined by GDPR are not new for companies in the clinical research sector, as similar requirements already exist in the regulations governing clinical research, such as ICH GCP E6 ‘Good Clinical Practice’. Many requirements are also similar to requirements to be found in local data privacy regulations in other parts of the world.
GDPR applies to companies and data subjects in the EU, but clinical research has become increasingly global in its scope and now a major clinical research member country is leaving the union. This article by Viedoc’s Quality Manager Alan Yeomans describes how different types of global clinical research projects are affected by GDPR and gives a detailed view of how GDPR applies to the jurisdiction of data subjects, sponsors and vendors.
To ensure the pricing fits your budget Viedoc has several add-on features that can be included if needed. For studies that don’t 予算に合った価格設定を提供できるよう、Viedocにはいくつかのアドオンがあり、必要に応じて追加できます。 追加機能を必要としない試験では、このような機能への支払いは不要です。 試験に必要な機能があれば、試験に合う機能をライセンスに追加できるのです。
In Viedoc the investigators always have access to their data
The ICH GCP R2 requirement states that "The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data."
Whether or not the investigator has control of and continuous access to their data is not a function of whether or not the servers are remote, but of other aspects as well:
Are these servers under the control of the sponsor? For example are they servers owned and operated by the sponsor?
Does the sponsor regularly disable investigator access to their data, for example after database lock?
Viedoc servers are under the sole control of PCG Solutions who are a trusted third party, the data is not under the exclusive control of the sponsor. After database lock the investigator can still logon and view all of their data in Viedoc, they are no longer allowed to change their data but the ability to change the data is not demanded by ICH GCP, only that the investigator should have continuous access to it.
At PCG Solutions we are active not only in following all relevant international regulations and guidelines, we work actively with the authorities to ensure that we have a full and correct grasp of their expectations and we develop and test Viedoc to ensure compliance. Viedoc Performance Qualification (PQ) contains a special regulatory test suite that is executed on every release of Viedoc to ensure that the regulatory compliance has not been compromised.
You do not need to export PDFs to store at the site, Viedoc guarantees that your investigators have continual access to their data at all times.
If you have any questions regarding the interpretation of this requirement, do not hesitate to contact us.
Why nominate for the Viedoc Most Valuable Professional Award?
The passion born from improving electronic data capture for clinical trials is still our greatest goal and this has made us a leading provider in the industry. This goal can only be accomplished by the communication and collaboration we have with our users. That is why we have now introduced the Viedoc Most Valuable Professional (Viedoc MVP) award. The Viedoc MVP is given for outstanding contributions within the Viedoc community and to acknowledge those who are willing to share their passion, technical expertise and real-world knowledge of Viedoc, electronic data capture or clinical trials. A Viedoc MVP is awarded for individual contributions and the nominees are selected exclusively by the PCG Solution’s management team based on a review of accomplishments and achievements.
This year, we have given our first Viedoc MVP award to Makoto Yokobori at the User Group Meeting held in Tokyo on 13 June. Mr Yokobori was the first user to get our back end set up training back in 2008. Since then, he has gained and shared in-depth knowledge from all aspects of conducting clinical trials using Viedoc. Mr Yokobori is a true ambassador for good clinical practice and includes this thinking in the study design and how systems can best be incorporated to support and raise the quality of the study. He is full of ideas and has a strong interest in improving and developing the industry, much like why Viedoc was born.