What is the role of the CROs in the industry?

Contract Research Organizations (CROs) play a key role in the development of clinical research due to their number of resources and adaptability. But why have their uptick in the recent decades become so notorious?

Traditionally, pharmaceutical companies would include all phases involved in the research activities in their operations system. The emergence of innovative techniques and work philosophies that help increase competitiveness has created the need to stay up-to-date and increase either the qualification level of their staff and the resources available or outsource some services to specialized companies.

The data of its evolution are impressive: Since year 2,000, pharmaceutical industry began to delegate the activities of protocol design, approval from authorities, field trials, statistical analysis… to new companies. In less than a decade, the know-how of the CRO’s market made their annual growth out of 15%, employ 70,000 people and nearly 10,000 clinical trials had already been conducted.

CRO’s must be able of reach an efficient project management system that will meet the quality requirements and based on clearly defined objectives that will guide the testing development. Each project has its peculiarities and demands, so in Tests&Trials we adapt our working methodology to ensure that the most appropriate steps are taken.

By providing their knowledge and experience, these organizations accomplish the reduction of the development time of the new products by establishing efficient control mechanisms which allow them to act quickly and to implement corrective measures on time.

What does the CROs activities involve?

The services offered provide advantages in terms of cost, quality, speed of field trials (when greater amounts of resources and efforts are required), better organization of the project execution (thanks to specialized organizational procedures for each trial) and the registration and commercialization of the products.

Clinical and nutritional trials are field experiments with animals in which products are tested and their safety, efficacy, and quality are evaluated and verified. This ensures that the market is provided only with those that ensure animal welfare and food safety.

There is much controversy regarding the ethic of these practices. However, not only is there a legal obligation to execute these trials, but also it is important to remember that the objective is to prevent that harmful products from being supplied to the animals themselves are supplied with harmful products. Tests&Trials take their care seriously and implement the Good Clinical Practices (GCP) that assure that no animal is harmed.

The trials consist of several phases. Some CROs offer comprehensive assistance in which they assume the entire project responsibility, but others are specialized in only some specific phases. In Tests&Trials, we give our customers both options: being their trusted CRO in the full-project or in just some parts.

Phase I – Protocol development
Phase II – Execution of the tests
Phase III – Statistical analysis
Phase IV: Final report

We keep up to date with the legislation in force and adapt to any changes that may arise for compliance. We also take care of the evaluation and approval by the authorities and the Ethics Committees that set out the basis for the tests.

How to find the CRO that will be best adapted to my demands?

Tests&Trials has all the flexibility to need and is capable of face challenges due to the multidisciplinary and motivated team we are.

The decision of whether or not to outsource (and who to trust on) is key to ensure optimal performance results.

To increase the success rate, it is important to be demanding in terms of meeting the established times and costs given the public pressure to obtain veterinary products with more competitive prices. The competition within the market is too high to delegate research processes to companies unable to quickly solve unforeseen events and to provide maximum precision in the tests.

Innovation, impartial perspective that guarantees reliable and precise results, proactivity, availability of resources, continuous process improvement, Lean Management philosophy… are requirements that must act as a complement to a excellent project management system. This is where our value relies on.

Do I want to delegate part of my project or do I need a CRO that offers a full-project service? And… Can I request their involvement in more phases if my expectations with the services are met? Or will they need a long period of adaptation?
Have I specifically asked about their resources to verify that they can deal with the investigation?
Does the team have the specific qualification?
Do they work implementing the most demanding and innovative quality practices that ensure the best process management?
Will I be fully informed in real time about the process/ trial evolution?
Is their corporate philosophy like mine in terms of animal care and welfare?
Are they up to date on current regulations involved in all the phases?