After an extensive evaluation and piloting major EDC products over a period of two years, a globally operating top ten Pharma company with headquarters in Europe decided to do the scale-up of their EDC programme with PhOSCo. This short case study describes the reasons which led to this decision and the solution approach for the programme.
During the evaluation period the insight grew among the major decision makers of the company that the ability to scale up the EDC solution on a global basis was the single most important decision criterion for the selection of a product and business model.
This insight led to some major requirements not usually found in product evaluation checklists:
Easy internalisation of the development of eCRFs and shortest possible time to first patient visit, using existing clinical staff. The ease, interactivity, and speed that a potential solution could provide in developing the eCRF and Clinical protocol was critical; the solution had to reduce the number and complexity of tasks required together with the number of people involved The objective became to transform as many existing Clinicians, CRAs and Data Managers into "e-certified" trial experts as possible. This meant that the solution had to be capable of accomodating non-IT literate people for these tasks and that the building of an eCRF should not be done by scarce IT resources, avoiding the need for extensive and repeated dialogue and review with Clinical staff .
Avoiding a dependency on small companies was critical success factor, based on analysis of the current market environment and Clinical software providers . The danger was in terms of risks regarding software delivery and future maintenance as well as their limited capability to scale up to the requirements of the programme in terms of skilled and trained personnel. Therefore international service partners had to be readily available to complement the internal resources and the business concept had to be open to allow the addition of further partners when required.
The solution had to be open from a business and technology point of view. It had to be open from a business point of view so that new requirements could be accomodated in different ways; performing tasks inhouse, working with partners, cooperation with other entitities (academia or other Pharma) or any other business model representing any combination. From a technology point of view the solution had to be based on open standards readily available in the marketplace: Java, SQL, XML, and the Internet to allow simple and effective integration with downstream applications.
A key requirement was the need for a hybrid communication model providing the benefits of online working while avoiding the resilience, performance, and functionality limitations of online systems in an international environment.
Other important factors included:
A simple and easy rollout process. While the environment must be validatable, all other factors could not be bought at the expense of the need for a complex or lengthy installation process.
The need for a simple and preferably automated process for maintenance of trial customisation and the software itself during the lifecycle of a trial, together with the capability of normal business change control management.
Ease of Internationalisation and multilingual capabilities including Asian languages.
The PhOSCo product was rated as being the most modern, open, and scalable solution building on many years of experience with its predecessor ClinWare, while fixing that product's major shortcomings by the addition of a hybrid communications model and a total rewrite using modern technologies and standards.
The PhOSCo Open Source, Open Business, and end-user capabilities meant that all requirements which were limiting scale up could be overcome and that internal IT and business resources could be motivated to take ownership of the solution :
No contractual or business model constraints were imposed by the PhOSCo concept. The company was in full control of all risks associated with such an ambitious programme of change.
The ability to be in full control of its own destiny by taking the responsibility for the code development and integration inhouse was seen as a major differentiator. It also meant that all company specific extensions could easily be accomodated and included into the solution.
The capability to train non IT people to develop eCRFs meant access to existing resources in all current departments making the transition to electronic trials much easier.
The choice of service partners ranging from global organisations to smaller specialised niche players led to a competitive and rich marketplace for complementary resources
There was the recognition that the PhOSCo software has the potential to be developed into an interactive protocol design solution upstream as well as a seamless and integrated review and analysis solution at the backend without having to use legacy data management systems. The ease of making it a a fully international solution covering Japan and multilingual environments was seen as a big advantage.
The low cost of the software facilitated funding the investment to internalise the solution was facilitated. All value calculations performed showed that the PhOSCo model coupled with the internalisation of the product and eCRF development led to a much better cost envelope than any other solution.
A broad Change Management programme has been initiated leveraging the capabilities of the PhOSCo product and the open service model
Global Support teams are set up to handle Logistics and Operations of electronic trials with the objective to internalise eCRF development and trial support on a global scale. Company Standards are developed and deployed using the advanced functions of the PhOSCo product.
Clinicians and Data Managers are trained to develop eCRFs with the PhOSCo Builder Component based on the Company Standards. This allows a significant increase in delivery capability and considerable reduction of the time to develop electronic trials compared to other approaches.
The PhOSCo Clinical Trials in Java Object Framework is being internalised in order to do further development and maintanance integration and packaging of inhouse while profiting from the extensions being provided by the Open Source community. The Development team is located in the USA and provides the EDC product to the entire company. The internal staff is highly motivated and is currently focusing on developing company specific extensions. Developing in an Object Oriented environment using Open Standards, XML, Java, SQL, and modern state of the art, non-proprietary technologies is seen a a job enrichment by the developers.
IBM as a global service partner is helping to jump start the internalisation by providing validation, training, and other professional services. A production infrastructure hosting the central servers of the PhOSCo solution is also provided by IBM.
Smaller service companies and contractors are complementing internal staff and IBM in specific areas where economically meaningful and advantageous.