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European Pharmaceutical Contractor

The Age of EDC

Gregor Spiekermann of Merz Pharmaceuticals GmbH reviews partnerships between CROs and EDC service providers, highlighting a move towards improved strategic outsourcing

Over the last decade electronic data capture (EDC) has become a de facto standard for the pharmaceutical industry. Its implications not only include changes in the design and conduct of clinical studies, but also new opportunities for partnerships in clinical research. A growing demand for flexibility in trial designs on the one hand, and for sourcing on the other, caused a shift from paper-based to electronic trials. The actual numbers of globally conducted trials – paper- versus EDC-based – are hard to estimate. However, the general impression is that EDC has already overtaken paper trials, not only in strategic importance, but also by the number of trials initiated.

THE LAST DECADE

At the beginning of the millennium, EDC had already been envisaged to be the future technology, but what has caused its slow adaption over the last 10 years? There are several reasons for this given by limited capabilities of the EDC software in the past – EDC client software installations were required, complex system configuration were common and computer and network performance issues played a bigger role than they currently do. Furthermore, scenarios with application service providers (ASP) were not well elaborated, meaning CROs had to implement and validate IT server infrastructure for EDC to offer sponsors professional services – a task only feasible for the larger CROs.

Several vendors with limited resources for EDC software development populated the market at the beginning of the millennium. Concentration on the EDC vendor market has reduced the number of competitors significantly. This concentration has not only occurred for small and medium-sized vendors; the 2010 acquisition of Phase Forward by Oracle reduced the number of global market dominating vendors as well.

TODAY’S OPPORTUNITIES & CHALLENGES

The challenges for competitors have changed over the last decade, showing increasing market maturity. Customers do not just expect a stable running application; today’s market has to face the demands of cost reduction and process improvement of pharmaceutical companies due to expiring patents of profitable brand name drugs.

The two examples given below illustrate how efficiency and process improvement evolved within EDC architecture:

  • Modern EDC architects use the internet for secure online data transfer and do not require any client installation, which caused several issues in the past. For EDC users, such as site personnel and CRAs, the use of eLearning to train role-specific EDC functionality is well accepted and has, for the most part, replaced conventional instructor lead training.
  • State-of-the-art EDC can cover the demands for all phases of pharmaceutical research. The approach to adaptive trial design and the handling of large, global, multi-site trials are particularly advantageous compared to the paper-based approach.

When talking about EDC, one usually also talks about an integrated data management component. EDC provides a framework for the integration of various systems and devices such as IVRS/IWRS, ePRO or CTMS. Integration of data from these systems is quite common, whereas comprehensive concepts of a middleware and portal integrations are still a point of interest for both customers and vendors.

EDC PARTNERSHIPS

Besides the technical software improvements there were also notable changes in collaborations. The framework for these changes was given by the global trend of switching from tactical towards strategic sourcing models for partnerships between sponsors and functional service providers. Current R&D strategy approaches with a high demand of flexibility in all directions have caused this restructuring of the market.

From classical CROs, service providers and niche specialists the trend is moving towards ASPs, who have core skills in EDC IT infrastructure, eCRF setup, edit check programming and hotline services. In addition to this spectrum they also offer certification programmes for CROs to deliver the EDC-related data management services for trial setup. Even small niche CROs can join these certification programmes for EDC without having an EDC software implemented in-house. This partnership approach between a CRO and an EDC service provider allows a sponsor to take advantage of a qualified ASP and a functional service provider team with special, combined knowledge. Due to a better networking of EDC providers and CROs, sponsors are able to reduce their risks and keep the costs of a new trial manageable, without compromising on quality.

The broad spectrum of outsourcing can result in additional work for the sponsor in the selection phase. Due to the large number of functional service providers for EDC there has to be a strategic way of deciding who to use; this probably explains the increasing number of conferences on strategic outsourcing and partnerships.

MANAGING FUNCTIONAL EDC PROVIDER PARTNERSHIPS

The ‘Responsible, Accountable, Consulted, Informed’ (RACI) Matrix is a helpful approach to get an overview about cross-functional responsibilities and interfaces between collaborators and is used for project management in different industries (see Table 1). The approach can also be useful for planning clinical trials. Rows indicate the work packages while columns show the contribution of the respective collaborators.

In the example given, a sponsor works on a hosted EDC system with a partner CRO for data management and another CRO for site monitoring. Integration of the EDC system with IVRS and an external laboratory are given. The sponsor has the overall accountability for the tasks (A), but delegates responsibilities to partners. For each work package a unique responsibility (R) should be assigned. The supporting providers, for example the provision of information, are indicated by (C). (I) indicates if information is simply passed over.

The example in Table 1 visualises the complexity and related communicational efforts that are introduced in multiprovider scenarios. Things get easier when working with preferred partners (see Table 2). The reduction of complexity reduces inefficiencies due to communicational efforts and speeds up processes. However, the final decision for a certain scenario will vary from sponsor to sponsor and will also be based on strategic aspects. In this sense the two examples are simply illustrative and a sponsor can choose to experiment with a multitude of options.

EDC INTEGRATION

While the functionality of EDC systems has evolved over the last 10 years towards more usable and ergonomic solutions, it is surprising how similar the products of different vendors are today. This illustrates, to some degree, how mature the solutions are. However, there is still room for improvement over the next years. Integration of EDC with systems such as CTMS, IVRS/IWRS and ePRO are quite often used, but real-time integration of lab data, as well as data from medical devices, still causes issues. The CDISC standard is also slowly expanding, but a higher motivation for vendors would be beneficial. The EDC core products will be more comprehensive – functionality will still grow in the direction of CTMS and replace it in future system releases. The same will happen to medical coding functionality.

EDC & EHR

Future visions of eSource show EDC in a different light. While EDC is currently the source of data for clinical research, electronic healthcare records (EHR) will bring a more integrated approach. One disadvantage of EDC is the requirement for sites to duplicate data from the mostly paper-based patient records to the eCRF. It is one major source for errors and time delays. This step can be avoided by using electronic patient data, primarily for healthcare use, but additionally it could be directly transferred for secondary use in clinical trials. There are promising investigations in that direction by CDISC. What hinders the progression from EDC to eSource is not a lack of technology, as was the case when switching from paper trials to EDC, but instead it is the unclear and overlapping scope of regulatory requirements that have to be fulfilled with regard to healthcare or pharmaceutical approach. This has a direct impact on the scope and strategy of the information system validation. The aim of both is the privacy and integrity of patient data, but so far there is no joint initiative. Privacy is also a very sensitive field when working with patient data in electronic networks. The possibility of human error has to be taken into account here, too. Approaches with the patient as the approver for giving access to his or her data by an electronic key could help to increase security and keep things manageable.

CONCLUSION

EDC has made it to the top and nowadays there are good systems and flexible services on the market. Looking back at paper-based trials they will seem romantically slow and charming in comparison. Over time, the worldwide web, IT innovations and clinical research requirements have built a foundation for global and operational use of EDC. Hosting services for IT infrastructure and functional service providers enables the sponsor to quick-start with EDC and benefit from the IT expertise of the partners. This gain of knowledge provides sponsors with a competitive advantage, allowing them to sharpen their profile of internal knowledge as the option to switch to a more suited service provider is usually costly and time consuming. This reduces risk and opens perspectives for strategic, quality-based partnerships. The vision of a single source approach is convincing, but there seems to still be a long way to go. One thing is clear – the integration of EHR with EDC is promising but who will be the driver for its adoption on the market?


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Gregor Spiekermann is Head of Clinical Information Systems in R&D at Merz Pharmaceuticals GmbH. As a qualified physicist he has more than 12 years of experience in the field of IT management in the life science sector. His professional interests lie in the area of paperless clinical trials. In his current position he has been focusing on electronic workflow optimisation and system integration in R&D for more than five years.
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