IT solutions in clinical trial management

NNIT's Philip Puls and Onorach Ltd's Christene Leiper on how to optimise performance management by delivering better analysis and planning tools.

Thanks to rising costs and longer development cycles for new drugs, pharmaceutical R&D departments are facing an increasingly challenging business environment. What strategies can pharma companies use to help meet these challenges?
Philip Puls. NNIT recommends companies to evaluate their overall clinical development process with the aim to optimise each step for maximum efficiency and alignment to the overall process. A cornerstone of the outcome is setting up a company-wide IT strategy with strict executable elements. This requires a breakdown of silos and a reinvention of the clinical landscape. Companies must define a larger vision and architecture, develop improved processes based on identified gaps, build business cases for each chosen project area, and then initiate the projects in the best sequence.

The approach from NNIT, called eClinical, is not dictating a single solution that fits all companies; it recognises that all companies have varying organisational restrictions and specific challenges, which must be taken into consideration. Based on careful analysis, the objective of the NNIT eClinical process is maximisation of benefits for the R&D organisation according to the priorities.

Christene Leiper. Use an outsourcing model that involves working with innovative CROs who have specific services designed to produce robust data, shorten the length of time taken to run clinical studies, and reduce the time to get new medicines to market.

Make certain that the study design meets all the questions being asked to prevent any protocol variations occurring.

Crucial steps to ensure the success of studies are site selection and engagement. As it takes time to achieve the required number of patients, pharma companies have to develop a plan for successful enrolment, bearing in mind the challenges such as geographical location, before devising their approach. They also need to define an acceptable cost per patient, which means defining a budget. Principal Investigators can accelerate recruitment by screening patient records, by using ICD-9, an international classification of diseases, or by assessing 'billing codes', thus identifying the disease. Referring physicians can refer their patients for screening. To assist the physician, a dedicated staff member can complete this task effectively.

What specific tools can companies use to create a more flexible clinical trial management process?
CL. Companies need to apply intuitive technologies so that data from various sources in different countries can be converted into a common, accessible format. These technologies should be flexible, familiar, and user-friendly so that clinical collaborators can manage and share information concurrently anywhere in the world. Web technology makes it easier for clinical trial managers to find, update, and share the right information where and when they need it. By having all this information at their finger tips, clinical trial managers can make the best decision about continuing a trial, stopping a trial, or adding an amendment to the protocol.

PP. At NNIT we believe two types of tools can facilitate more flexible and agile system landscapes. The first tool focuses on the organisational ability and maturity. The organisational tool comprises standardisation and a governance model for enforcement and development of standards. The second tool is based on the introduction of new components into the application landscape, more specific single repositories for sourcing and maintenance of master and meta data connected with a service oriented architecture (SOA) allowing easy access across all applications.

The SOA approach enables plug-and-play of software products, which ideally allow access to the best of breed solutions enabling optimal processes and functionality and also creating the necessary flexibility. Another solution featuring end-to-end integration is to sign up with a full suite provider that covers EDC/CDMS, CTMS, CDW, BI and safety system, with the expectation that they can provide the required architecture and functionality in a timely fashion.

Why has it become necessary to move away from legacy systems towards a modular architecture based on browser/web access across organisational and geographical areas?
PP. The short answer is high total cost of ownership (TCO), low user satisfaction, lack of cross company collaboration and inability to get access to best of breed solutions. The current situation for many companies can be summarised in the following issues: significant delay in access to data, difficulties to create a clear picture of historic or current performance/results, the creation of integrated reports of data is slow and resource intensive, while resource and portfolio management is rudimentary. This is caused by having data in multiple, non-integrated silos, data keys and in formats that are inconsistent between systems. 'Old' systems don't support new ways of working because they are not flexible enough and build on old technology. User interfaces are not intuitive and adaptive to business processes and therefore require specialisation. In the cases where bespoke interfaces have been established to facilitate data exchange, the companies find that it now becomes an even bigger task to maintain and support the users.

CL. Pharmaceutical companies often use multiple data sources such as ERP, Microsoft Project, Excel spreadsheets etc, to define and manage clinical trial processes. However, these systems have their limitations not only because the data is so complex to access or understand, but also due to the inconsistencies in the way people input their data. Moreover, existing technologies use widely differing data standards and this hinders integration. The result is that clinical site managers waste a great deal of valuable time converting critical data files into usable formats, thus increasing the risk of human error.

Life sciences companies need to apply efficient technology solutions to help manage the flow of information at investigator sites. These solutions must promote collaboration between remote clinical researchers all over globe and enable data exchange across technological boundaries. Solutions need to be flexible but also secure so that intellectual property is available to the right people at the right time.

How do you see the use of IT solutions in clinical trial management evolving over the next few years?
CL. IT Solutions will continue to optimize performance management by delivering better analysis and planning tools. Companies can apply software that improves their ability to make timely, informed decisions in all areas whether clinical R & D, manufacturing, operations or finance.

Software will become an important strategic tool for clinical trial management and will carry much greater weight in developing processes to increase clinical efficiency and optimize costs/value for money. Software provides the tools enabling you to monitor performance against the key milestones such as investigator selection, site initiation etc.; combine your plans and budgets in order to clarify spending, predict expenses, and maximize financial capital leverage; and better plan and analyse key performance indicators (KPIs) which will certainly improve the effectiveness of contracts.

PP. There will be a single sign-on to a clinical portal from any client (Windows/Mac, PDA/Smartphone) from any corner of the world. The user interface will be a browser of choice with a common look and feel for all the systems. The portal will provide access for in-house as well as external resources to share data and information. It will be connected to the company's document repository, clinical data repository, operational data repository, safety data repository and provide access to a number of preconfigured reports with drill down capabilities all relevant for the job hold by the user. This will remove a large workload for trial managers, with respect to create and distribute progress reports of trials.

Furthermore, a number of predefined workflows will be available to secure fast and seamless execution of key business processes which often will be event driven. Finally key business processes will be automated by use of metadata, enabling fast and reliable report generation and data pooling.

The Panel:

Philip Puls is Senior Programme Manager at NNIT. He has 20 years of experience in the life sciences industry specialising in the implementation of standard solutions in clinical development. He has a deep pharmaceutical business understanding, high regulatory and technical expertise and has worked as a Project Manager with CDW, eClinical process optimisation, EDC and safety system implementation projects.