08 Jun New discoveries can speed clinical translation
Clinical translation can speed the knowledge that new discoveries imply and it can even serve to increase the research related to the discovery and its application. As an example, we are going to pick a recent discovery concerning stem cell therapies. We are referring to a new more efficient approach that consists on reprogramming diseased skin cells into stem cells for any patient.
With a precedent in 2006, the main importance of this discovery is that as regenerative medicine, it implies unlimited source of patient-specific cells suitable for transplantation. Therefore, Okomeds, as a life-science translation provider, and CROs translation provider, is interested in echoing this interesting discovery that has already arisen much interest among the medical community.
It is also important to point out that in the referred to case, the immature embryonic stem cells that are been reprogrammed, can be grown in or outside the body, transplanted or used for research and genetically manipulated. However, the technology, although promising is not yet well enough developed to guarantee safety for clinical applications.
CROs role is crucial when there is a shift from the laboratory to clinical trials
From new discoveries to clinical translation
Nevertheless this new discovery means that simple manipulations of the RNA molecules could affect the efficiency of reprogramming. Specifically, manipulations of dosing of the RNA molecules or of timing. Therefore, improving reprogramming efficiency, especially if the process is done at a reduced cell density, due to the direct correlation between the rate of cell division and the efficiency of reprogramming.
As CROs are increasingly involved in clinical research and concentrate wide expertise in clinical design, therapeutic areas, geographical areas, or contract research regulations, they are increasingly considered strategic partners to pharmaceutical, biopharmaceutical, or similar companies. Even Universities can act as CROs.
In this sense, CROs role is crucial when there is a shift from the laboratory to clinical trials. And this is the current stage of the recent discovery we used as an example. Once the shift is produced, translation services also achieve an important protagonism, as clinical trials need clinical translation.
Clinical translation holds great potential for the development
Both the trials and their translation hold great potential for the development, especially when we are talking of a discovery as the one of the example, that can mean new corrective stem cell-based therapies that can be applied for currently incurable diseases. At the same time, clinical trials and clinical translation can help setting the standards for future therapies for other diseases.
Being able to provide the right information to the right people, through the right channel and at the right time, can be key for successful communication of any discovery and for the clinical trials that must follow. Potential delays and bottlenecks can be avoided by the adequate intervention of specialized translation services, reducing the number of intermediaries, improving comprehension and minimizing the level of noise.
Quality assurance is a needed goal. And, as regards translations for CROs, it involves planned and systematic actions to ensure performed and generated data are correctly documented and reported in compliance with the regulations in force. In this sense, we must highlight that trusted clinical translation and translation services shall be a part of the implementation of a quality management system for any medical product development.
To conclude, we would like to say that since it takes years to develop new drugs or products and clinical trials can be unpredictable, a strategic partnership between CROs and Medical Translation Services, and also between Sponsors and CROs, may not only be useful in times of crisis, but also in the long term. This means that choosing the right partner is essential, not only to avoid relationship pitfalls, but also to guarantee effective clinical translation, communication and consistency.