Monitor Clinical Research Tools – a novel ICT solution for remote monitoring of source medical data in clinical trials

Project Information

MCRTOOLS

Grant agreement ID: 729376

DOI

10.3030/729376

Project closed

EC signature date 15 June 2016

Start date 1 July 2016

End date 31 December 2016

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

MONITOR CR SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA
Poland

Periodic Reporting for period 1 - MCRTOOLS (Monitor Clinical Research Tools – a novel ICT solution for remote monitoring of source medical data in clinical trials)

Reporting period: 2016-07-01 to 2016-12-31

Summary of the context and overall objectives of the project

The objective of the project is to commercialize Monitor Clinical Research Tools (MCR TOOLS), the first IT system enabling complex support of the clinical trials process for all stakeholders. MCR TOOLS support the process of clinical trials, providing innovative organizational and technological solutions. We are creating software that maintenances process management and data monitoring in clinical trials.

Clinical trials are used to determine whether a new medical treatment are both safe and effective. They are expensive and time consuming processes and absorb 68% of the total cost of the drugs development. Clinical monitoring is an oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials. Sponsors of clinical trial sends their representatives (called Clinical Research Associates – CRA) to the Sites, to directly supervise the conduct of the study. Clinical monitoring accounts for 20-40% of the cost of a clinical trial. A steady increase of overall data monitoring costs, coupled with growing awareness of the value that could be generated by streamlining administration procedures in clinical research, is expected to drive demand for new IT tools streamlining and automating data monitoring processes. This provides a strong business opportunity for new market entrants that can address the issues of:
- Excessive length and overly high costs of clinical research (approx. 10 years and EUR 360 mln)
- Problems with software integration towards the established systems - hospital information systems have different versions of the HL7 standards or they are not compatible with accepted standards (HL7)
- Cumbersome workflow and non-optimized clinical trial management – human errors and delays in clinical studies are caused by the size, complexity and load of paperwork in these studies (approx. 80% of clinical trials are delayed)
Source medical data transfer and monitoring remains the last aspect of clinical trial management which has not been automated, streamlined and digitized yet. The deficiencies of existing IT solutions combined with the vast market demand have created a distinctive niche on the market for IT tools for clinical trials. Both Sponsors/CROs and clinical sites await a fresh approach to data monitoring problem. Monitor CR will capitalize on this demand.

The social aspect of the project relates primarily to patients - clinical trial participants. The participation in clinical trial is an opportunity for them to access innovative drugs and therapies as well as advanced diagnostics and diligent monitoring of their health status. Patients who participated in clinical trials have an opportunity to make a personal contribution in the development of medical knowledge, as information obtained in the course of clinical trials enable to create increasingly effective and safe treatment methods. But there is a problem regarding the safety of patient data in the system. The primary responsibility for monitoring the safety of participants, and the correctness and accuracy of data in clinical trials lies with the trial sponsor. However, the sponsor as a stakeholder of the process cannot have access to full details about the patients taking part in a trial. It is a matter of ethical and scientific integrity. Precisely for this reason, the only possibility to perform data monitoring tasks today is by having the CRAs make on-site visits to the clinical site, where they can directly access the relevant medical source data but they are constantly shadowed by healthcare personnel. That is the one of the reasons why clinical trials are so time and costs comsuming processes. MCR Tools allows to replace a part of direct Monitor (CRA) visits in the health centre, providing remote access to the anonymized medical records of trial participants from any place and at any time. It could reduce of monitoring costs even by 40%. And lower cost of a single clinical trial can cause an increase in the number of clinical trials in general. This will ensure that new drugs, saving the lives of people around the world, become sooner available to patients.

The overall objective of the project is to ensure better organization of clinical trials and a significant reduction in the cost of their monitoring by providing and commercializing an innovative software MCR TOOLS.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The action taken during the Phase 1 project enabled us to develop a business plan for commercializing MCR TOOLS. The study identified the key factors and market constraints influencing future marketing & sales and confirm the market potential of the system. The analysed areas include:
- Market potential: analysis the demand for MCR TOOLS,
- Geography of the business: identification of the key European markets for the launch of the product,
- User needs mapping: in-depth analysis of the users' needs,
- Key stakeholders on the market: strategy to engage key stakeholders,
- Analysis of established hospital information systems: identification of key HIS providers in Europe and analysis the technological basis of those systems,
- Partnerships: analysis potential partners for marketing and sales,
- Strategy to reach the targeted users: development the appropriate strategy, taking into account the users' needs mapping; marketing & promotional strategies,
- Competitors: development a good understanding of the competitive landscape and existing market barriers,
- Legal and regulatory constraints: analysis all legal and regulatory aspects of the planned activities,
- The economics of the business: elaboration a financial projections and forecasts and definition the volume of sales needed to cover the expenses and become profitable,
- Capital requirements: identification future capital requirements to move the business forward.
We have also developed a business strategy in accordance with Monitor CR's vision, values and long-term development & revenue goals. As a main result of all actions taken, we have formulated the final business strategy and business model based on the results of all the analyses. The result of Phase 1 is a comprehensive market analysis with a detailed business model. Apart from developing the concepts of strategy, Monitor CR has also been conducting R&D works, implementing them and analysing the preliminary feedback received on their implementation. Currently, the IT system is on TRL-7, as it has already been successfully demonstrated in the operational environment at two leading clinical hospitals in Poland with the participation of one of the largest and most innovative pharmaceutical companies in the world. An outcome of Phase 1 is an innovation project that demonstrates high potential in terms of company competitiveness and growth, underpinned by a strategic business plan.

Monitor CR's dissemination activities with regard to MCR TOOLS include: presentations for hospitals and CROs/Sponsors to highlight various aspects of the system: legal, social, financial and economic; participation in the European thematic conferences and meet-ups (ex. UK e-health week, MEDICA Trade Fair, Life Science Open Space); publications in social media (Linkedin) and cooperation with business partners.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The Monitor CR company aims to capitalize on the identified technological gap and satiate the growing demand for modern IT tools assuring time and cost efficient monitoring of source medical data. MCR TOOLS will for the first time provide the users with truly remote and secure access to source medical data on-line and thus enable them to overcome the major practical and economic constraints in clinical investigations. The expected outcome of the overall innovation project is the product brought to full operational maturity (TRL-9) and the market. In this process, Monitor CR will be supported by the established network of partners and strategic investors. Combining strong user and market focus (expressed through Phase 1 feasibility investigations) with the technological excellence (expressed through the planned Phase 2 project), Monitor CR aims to redefine the established standards of clinical research monitoring. The expected commercial outcome is the accelerated growth, strong revenue development and new long-term competitive advantages.

MCR Tools integration scheme

MCR Tools login page