24 Abr Keys to success between CROs and Medical Translation Agencies

Clinical trials are more and more subject to outsource. In this sense, there has been an increase of 50% in the last decade and over 70% of the total number of clinical trials will be outsourced by 2020.

This tendency is consolidating due to its advantages for sponsors, as CROs can add value throughout the whole clinical trial process.

CROs added value in clinical trials

The reason is that due to their experience in specific fields, CROs are ready to identify the most common challenges and have practice in how to address them.

They are familiar with the best design from protocol to study planning, and know the best places or investigators to get particular data.

Medical Translation Agencies added value in clinical trials

However, clinical trials need translations, and selecting the adequate specialized medical translation services can be essential to meet the sponsor’s deadlines and quality required.

Therefore working with the right medical translation Agencies can have a significant influence on the ultimate success of a clinical trial.

In the same sense a vendor needs to determine what can the biggest specific threat for any trial be  before approaching the CROs, a CRO needs to take into consideration the risks of hiring inadequate medical translation Agencies.

In both cases, the selection criteria should be very clear in order to find the right company. Among these selection criteria, a key one is the necessary expertise to deal with the respective challenges during all the process and despite possible crises.

Any successful cooperation between CRO’s and specialized Medical Translation Agencies cannot be only related to the budget

In this sense, to run the trial or to translate clinical trials within the budget cannot not be the main or only reason to contract a CRO in the vendors’ case, or a medical translation agency in that of the CRO. We are talking about fields where selection is competitive, therefore there is a tendency to embellish each ones capabilities versus the contenders. To avoid misunderstandings, it is necessary to have enough time to ask for references, identify and address the right questions, or work with a company that has earned our trust during the time we have been working with them.

However, any successful cooperation between companies, such as CROs and medical translation Agencies or sponsors and CROs, in order to achieve a common objective also needs a good and pre-established governance structure.

– Flexibility and defined responsibilities

Responsibilities regarding problem management should be followed, establishing key performance indicators and deliverables for each party. Good communication can prevent a lot of problems, and can help to get the best possible solutions when problems arise.

A good policy implies defining roles and responsibilities, but also letting other parties to use their expertise to the maximum and avoid the unnecessary duplication of work.

At the same time, each party must have the flexibility to adapt to the needs of the other. However, needs and responsibilities for each partner should be clarified from the beginning. In other words, parties must ensure that their goals are aligned, especially considering timing, protocols and budgets.Keys to success between CROs and Medical Translation Agencies

– Project and documentation management

It is important to take into account that any project management needs assessment and contingency planning, but also, risk assessment, tracking, overall project planning, resource allocation,  communication planning. team management, auditing services, management of project timelines and deliverables, quality management…

But, also clinical trial development processes are linked to documentation management and facilitating commercial efficiency and cost effectiveness, and here a good medical translation Agency can be priceless.

The documentation management includes not only the design, but also the review and translation from the clinical trial protocol, to the clinical monitoring plan. Covering a large range of documents that need proper, accurate and expertise translation, such as, investigator brochures, Pharmacy manuals, master informed consent forms, Operations Manual, case report forms, trial master file and clinical monitoring plan.