The Challenges of Clinical Trial Management in Emerging Geographies


conducted in one region will be, more often that not, part of a much larger multi-site, multi-geography program. Novotech’s bespoke CTMS had served the company well through a number of years of growth. However, it became apparent that Novotech was outgrowing Novotrak and the company ran the risk of approaching a potential ‘plateau point’—where the limitations of the system threatened to negatively impact growth.


As a CRO, Novotech recognizes the importance of focusing on its core business strategy—the business of running clinical trials. Because the CTMS market has matured since Novotrak was developed, with a number of high-end, enterprise-class, commercial products available ‘off-the-shelf’, Novotech looked to commercial software vendors to source a replacement for the proprietary system. This decision was the start of a crucial evaluation process. The company needed a CTMS system that would support Novotech’s growth strategy; it would need to cope with the growth and development of the company and its expansion into new regions.


Benchmarking for Scalability and Flexibility Once the decision had been made to transition away from a proprietary system to a commercial product, the company began to establish its main procurement criteria by conducting a benchmarking exercise, using the functionalities and experience of the older system as the baseline.


As the owner of a proprietary CTMS, the inherent advantages and limitations of the system were well known to the company. Novotrak was developed in-house over a number of years and consisted of a basic structured query language (SQL) back-end with a dotNET front-end. The bespoke system incorporates a suite of modules covering every aspect of a clinical trial project and was designed to manage projects conducted in a number of geographic locations. Novotrak has been operational for five years but inevitably has encountered scalability and maintenance issues. Novotech recognized that by continuing with a CTMS based on a dated platform the company would increasingly encounter integration inflexibility with evolving iterations of solutions that feed into the CTMS, such as interactive voice response systems (IVRS), financial systems, SharePoint, and adverse event reporting procedures. For Novotech, linking the organic growth and expansion plans for the business with a dated system design and inferior interfaces could result in a misalignment of technical architecture to evolving business needs.


The replacement CTMS would need to provide functionality that facilitated the current workflow. It would also need to improve on the functionality of Novotrak with new features that were absent from the proprietary system. Novotech had to be confident that future requirements of the system, such as streamlining multiple workflows and gaining deeper insights into processes through analytics, would also be supported.


Another important criterion was that the new CTMS could easily integrate with the company’s existing technology. Novotech currently uses two electronic data capture (EDC) systems, Medidata and Viedoc, both of which have interactive web response system (IWRS) capabilities. The CTMS system would also be required to manage investigator payments and subsequent tracking. Further along the implementation roadmap is the prospect of integrating the CTMS with enterprise resource planning (ERP) software.


One of the key limitations of Novotrak was its inability to allow direct access to clients to specified areas of the system, which is essential for ensuring good visibility. To implement this capability, Novotrak would have required major investment in terms of software development. As mentioned previously, this would have detracted from the company’s core focus of facilitating clinical trials and was a major factor in the decision to procure a commercial CTMS system. Consequently, Novotech selected Oracle’s Siebel CTMS to support the company’s clinical drug development and research capabilities.


Implementation Challenges


HCL, an IT services company, has been selected to assist with the project management of the Siebel CTMS implementation. An important function within HCL’s remit has been to assess the capabilities of Novotrak, thus defining a benchmark for where the new system should be in terms of scalability and flexibility. HCL will also assist in validating the new Siebel CTMS, liaising with Oracle technicians, and will provide training to Novotech personnel.


Replacing a familiar, bespoke system requires investing significant resources in implementation planning. A critical factor for a successful implementation is to ensure that the right internal people with the right background are picked to work on the project. Accordingly, Novotech has designated a dedicated project team to work with HCL for the implementation process.


Another important element for a smooth implementation is to ensure the support and confidence of stakeholders within the company. This is an integral part of the change management aspect of implementing any new system and needs to be a component of the implementation strategy; identifying champions and key stakeholders. In Novotech’s implementation process the project team identified that the project managers were key to winning the support of those stakeholders, which will be critical for the successful implementation and adoption of the new CTMS.


A significant challenge in the process, in terms of the decision-making, concerns system configuration. The importance of this area should not be underestimated. A major investment in time and effort is required to ensure that the system is configured to meet business needs: all the different aspects and permutations of how the organization will optimally use the system. The challenge is planning these configuration requirements early in the implementation process, when access to the system is limited. Detailed configuration can only occur when the implementation is more advanced.


A Future-orientated Approach


Implementing the new CTMS represents a major plank in Novotech’s continuing strategy to equip the organization with optimal technology that will enable the company to reach its key business objectives. The Siebel CTMS will serve as a centralized repository for all investigators, which will allow the study management teams at Novotech to collect and track all relevant information about the studies in near real-time.


The organization’s expectations include eliminating the need for, or reducing the use of, manual and paper-intensive methods, such as one-off spreadsheets, and using email as a means to communicate and share documents. Integration, as previously mentioned, is an important factor. As part of the Phase III implementation, Novotech will


THE POWER OF CTMS—INTEGRATION, INTEROPERABILITY, AND COLLABORATION 15


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