Individual study concepts: Creating added value for young, growing research companies!

An essential task in innovative clinical research is to move away from industry standards and create sustainability for research goals. Based on many years of practice, it is evident that complex indications and special requirements for certain patient populations are difficult to serve with standard processes.

Innovative medicine develops holistic solutions for the prevention, diagnosis, therapy and rehabilitation of diseases and health impairments. For companies in this sector to achieve their goals, they often need far-reaching support in clinical research, among other things – because medical companies, especially start-ups and small and medium-sized enterprises, cannot realise this on their own. On the one hand, these companies can hardly maintain all the resources to carry out the entire development and approval process themselves. On the other hand, research-based medical companies often also need targeted external support to bring a product to market maturity and then actually position it on the market.

Individual and highly research-based study concepts do not necessarily have to fail due to complexity

The focus is on developing individual study concepts for these research-based companies in innovative clinical research. These lead away from the industry standard and instead create sustainability for research goals. After all, based on many years of practice, complex indications and special requirements for certain patient populations are difficult to serve with standard processes.

The problem: individual and highly research-based study concepts do not necessarily have to fail due to complexity. Practice regularly shows that even infrastructural imbalances and a lack of communication can torpedo study objectives.

The Research Experts Alliance (REA) knows from experience that wishes and research goals are often not fulfilled because a comprehensive needs analysis is initially lacking. At the beginning, it is important to create a suitable basis for a clinical research project so that a realistic budget and success planning can be defined. The large service providers on the market offer supposedly good and inexpensive all-inclusive packages, but experience shows that the small print in the service provider contract is overlooked. The consequence is that overhead costs for the expected transparency and implementation of the study are out of line.

If mistakes are made, the battle for resources and budget is pre-programmed

Initial budget ideas quickly lose significance in these scenarios since study procedures in large-scale service operations and expectations on the part of ambitious research companies differ widely from the agreed conditions. Be it due to a lack of consulting services and/or the non-transparent service structure of large providers on the market, which make the project no longer scalable. Once the study has started, there is often no turning back and by the end there is no budget left. The struggle for resources and budget is pre-programmed and cooperation is no longer efficient.

REA has often had to support clients in retrospectively reviewing phase II, III-IV studies and breaking up structures that were initially set up. These processes are very time-consuming, complex and, viewed prospectively, often leave no added value. The costs are considerable, and the resources are quickly exhausted. Unfortunately, we have seen too often that young, growing research companies have yield to the current market standard. A flourishing industry, however, pays little attention to the individual needs of the researching company, but rather to effective business development.

In recent years, it has been observed that diversification in the contract research sector is very much on the decline. Not least because large service providers have focused on a veritable oligopolisation over the past five years. This in turn means, above all, the standardisation of work and project structures and, under certain circumstances, a massive influence on and standardisation of the individual research and budget goals of a young research company. The trend is dictated by the large service sector, even if it cannot be served directly. There is often a lack of suitable specialists or resources for project implementation, and the individual needs of an ambitious research project can rarely be considered.

REA stands for high scientific and practical network competence

Therefore, it is important to generate real advantages for young, growing research companies through study concepts. For years, REA has been working in a trusting relationship with biopharmaceutical, biotech, pharmaceutical and medical device companies, creating sustainable added value for goal-oriented research. We experience it as an absolute advantage to expand growing research structures together with the client. In small project structures, companies grow and learn effectively.

REA stands for a high level of scientific and practical network competence from a wide range of industry sectors that pursue a common goal: creating innovative solutions for innovative companies. Coupled with personal consulting at eye level, we build a bridge between creative work and targeted research work. This enables us to develop smart and highly individual solutions and concepts for efficient planning and successful implementation for research projects.

Conclusion: It all comes down to the right planning!

Serious, transparent, and needs-oriented study planning is a must! For this reason, REA offers an individual workshop. In this workshop, precisely these cornerstones are laid to be able to start the implementation solidly and transparently. It is optimal if the business plan is aligned with this, and the financial resources are also organised directly at the start of a study in such a way that a study can achieve its goal. This is the only way REA finds to bring a study to a conclusion that is qualitative, timely and successful for all sides. This protects everyone from invincible challenges and creates the right focus.

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