Although they are a mandatory part of the procedure leading to approval of a drug or a vaccine for marketing, clinical studies are a long, complex and expensive process.
Reducing its time-to-market, increasing its ROI, remaining its competitive advantage, some of business issues for any healthcare company which directly express in this strategic business of clinical studies.
Discover how, thanks to a customized platform and support, a global healthcare leader succeeded in improving the efficiency of clinical studies management and thus saving millions of euros.
1. Business issue
In a context of digital transformation and change management, a global healthcare leader wants to improve the efficiency of large-scale clinical trials management.
In 2017, the company invested several billion euros in R&D. Each clinical study represents an average of more than 13.5 million euros per year. Internally, these hundreds of clinical studies involve several thousand employees and service providers.
Reinventing the process of clinical studies management has therefore become a major business challenge:
- For finance: saving time on the implementation phase and on the health authorities agreement translates into huge financial savings at the end of the process.
- For business departments: the complexity of large-scale clinical studies is correlated with the difficulties of execution and synchronization between all stakeholders. Increasing productivity, comfort and ease of execution for each business department will allow to save money.
- For competitiveness: in a highly competitive context, optimizing time-to-market will help to secure patents and exploitation.
The digital revolution offers new opportunities to optimize clinical studies. Besides, the change (2019) in the European legal context related to the initiation of studies (CTA package regulation), forces countries to align themselves as a single entity.
However, multinational companies face many constraints due to their organization and size.
On the one hand, each study is carried out in parallel in many countries that operate autonomously, which makes the optimisation of projects more complex.
On the other hand, the number of people involved tends to delay the detection of incidents during the implementation phase. It sometimes takes several weeks for a central manager to detect a problem in a country and as much to solve the issue locally.
Finally, reporting processes require a significant effort from all stakeholders, as the information is not automatically centralized.
Thus, the optimization of studies is translated into clear objectives:
- Reduce the cost of studies
- Improve the time to detect and resolve incidents
- Implement new processes for studies initiation to reduce time-to-market
In this context, this global healthcare leader needed a collaborative platform to manage its clinical studies with efficiency.
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3. Approach and solutions
The company considered 3 very different approaches:
a. Develop an internal solution
Multinational companies can develop a solution with their own IT teams. These teams are structured to design industrialized projects with very precise specifications to create the expected final solution.
Industrialization is necessary for any multinational company with ambitious business objectives. However, this process is unsuitable when it is about to create and develop a solution according to the maturation of the internal “business” need.
Indeed, defining precise business needs in such an innovative project is not easy. This choice can therefore be a source of disappointment. Both for business units that provide additional investment but also for IT teams that develop a solution that may not be adapted to business needs.
Moreover, the financial commitment for internal development is not appropriate, as ROI is still uncertain in this innovative project.
b. Mandate an IT service provider
Choosing an IT service provider is also an option: IT experts can develop or implement an existing solution.
However, this solution is expensive and sometimes inappropriate: the methodology is time-consuming and business units must be very specific in expressing needs, which is problematic in a context of immature and incomplete vision of the final solution.
Finally, existing solutions may not be adapted to the “business” and the culture of clinical studies. The additional development costs also represents a significant financial investment.
c. Collaborate with an innovative partner
The added value of choosing an innovative partner lies in the methodology: using a platform that offers more than a hundred unique and specific business components is relevant.
The main objective is to understand the need and deliver a first version of the solution in a very short time.
The solution can evolve very quickly thanks to a continuous improvement loop with frequent iterations. To do this, flexibility must be at the heart of the partner’s DNA.
The financial commitment is also progressive: the concretization of the project, the monitoring of KPI’s and the ROI allow the investor to easily justify his future financial commitment.
The pharmaceutical company chose this solution proposed by iRevolution for its initiative.
4. Choice of the solution and impact
The digital platform for the collaborative large-scale clinical studies management, taking into account business needs and the complexity of study processes in several countries, was created in 1 month.
Since then, a first “Proof Of Concept” phase has been carried out.
The iterations were immediately implemented (1 iteration/month) to model and implement business needs and recommendations.
This method was a source of internal motivation. Each iteration, adapted to teams’ needs, was developed in a very short time. Teams thus saw tangible business outcomes.
Real time management of clinical studies is now possible thanks to the platform, particularly thanks to dashboards to manage studies both at central and local levels. This platform also allows to clearly identify issues in different countries and to facilitate their resolution with action plans.
This platform, designed with iRevolution, became the central control point in 14 months and now manages more than 30 clinical studies.
Thanks to the platform, the company has achieved in one year an average optimization of 10% of the time spent on studies, saving millions of euros each year.
Today, the multinational company and iRevolution keep building the platform to predict and anticipate issues and further improve efficiency of large-scale clinical studies management.