Clinical research: complex research projects vs. industry standard vs. shortage of specialists

In addition to the emerging digitalization and centralization/decentralization of study processes, it has once again become clear since the Corona pandemic: skilled workers are disproportionately needed.

For years, there has been a shortage of personnel in the research environment, giving large service structures the security to market themselves effectively. Over the years, industry has shaped job profiles that now place utopian demands on a skilled worker. The jungle of job titles, the expected expertise and scope of performance within the framework of personnel capacity have reached a level that has little to do with reality.

Thus, for example, job descriptions are completely dismantled, and essential areas of responsibility and core competences are completely distorted. The consequence is that the focus in project work is no longer on core competences and the target-oriented implementation of work processes. If possible, one person should map several requirement areas and work processes in parallel. Essential aspects for the goal-oriented implementation of work processes are delayed or not implemented and seep away in non-transparent service structures. In case of doubt, this unfortunately also makes itself felt in disproportionately high overhead costs and in the quality of studies.

On the other hand, the job profiles shaped by industry do not actually exist. Differentiating suitable professionals becomes opaque and desperately sought expertise remains hidden, even though it may already exist.

Offering an alternative to the industry standard for start-ups and small and medium-sized enterprises

From practical experience, the Research Experts Alliance (REA) knows that the procedure within large service structures is observed suspiciously by competent authorities and ethics committees. During various audits and inspections, ICH-GCP standards have been assessed and criticized, as they are often burdened with overloaded processes and requirement profiles for respective experts. The additional work for all parties involved and the explanation of the circumstances too often leave open questions regarding data quality and implementation of study objectives.

REA has created a network of experts over the years to provide an alternative to the industry standard for start-ups and small and medium-sized enterprises. We want to support growing research companies in defining their own independent research goals and actively bringing them into the planning process. We support with strong partners at our side to plan possible research goals and company definitions from scratch. We see an absolute added value in “helping people to help themselves” and accompany our clients and partners on all their paths to individualization.

REA experts provide support throughout the entire study preparation and implementation process.

Our goal is clearly formulated: We want to promote medical innovations through our competences in clinical research, project management and strategic planning and thus closely accompany medical companies on their paths. All players in the health care industry are called upon to make medical innovations and their positive effects for society and the economy possible through close cooperation.

The REA experts support the entire study preparation and study implementation, including study result analysis, and jointly develop individual post-market concepts in close cooperation with clients and network partners. In doing so, the experts provide assessments and ideas for improving the acceptance of a product, analyse the risk-benefit assessment and support regulatory implementation. Effective patient recruitment ensures that the right patient population is differentiated for the appropriate study objective.

Cooperation to open access to innovative funding sources

Incidentally, REA’s clinical trial experts and StructuredStrategy, a Hamburg-based consultancy for digital project and corporate financing, are working together to help pharmaceutical, medical technology and biotechnology companies successfully develop their markets. In doing so, they offer the industry access to innovative sources of financing and support especially young and smaller companies in obtaining the capital they need while positioning themselves as broadly as possible. This opens market access and forms the basis for long-term entrepreneurial success.

The experts identify the best investment platforms for a company’s individual issues and open innovative ways of raising capital, including regulated crowdfunding, bond issues, private placements, private equity and/or debt capital and hybrid/structured financing products. Companies and projects are made attractive and visible to suitable private, semi-professional or institutional investors through specific measures and are accompanied in legal and economic matters during negotiations with investment platforms and investors.

Creating the basis