In recognition of these trends, many CROs have expanded the number of services they offer. This has seen them move past simply helping with day-to-day operational tasks, and major CROs can now handle almost any aspect of the trial process and related activities.
Regulatory affairsOne area of drug development that pharmaceutical companies often struggle with is the regulatory stage. This final phase of drug development is the last hurdle before a drug reaches the market and is beyond the control of companies. There are often problems as the process involves an external regulatory agency that reviews the data in an independent fashion. As regulatory agencies are government bodies, and thus accountable to the public, public safety is paramount and their decision-making must be geared towards this factor rather than a company's hopes and expectations.
The outcomes of regulatory reviews cannot be predicted, but companies can be better prepared by planning ahead and seeking good advice on regulatory options and guideline changes. If a sponsor is using the services of a CRO that has a regulatory affairs department, it would be wise for the sponsor to consider asking their opinion. As CRO regulatory affairs personnel frequently deal with regulatory agencies, they often build up a more realistic picture of what is expected, whereas a sponsor can be overly biased because of expectations for a specific product. In addition, CRO regulatory personnel tend to work concurrently with numerous agencies in different global regions across various projects, whereas the sponsor is often limited to national markets for a set number of products. This allows CROs greater insight into the nuances of decision-making within regulatory agencies. Companies accustomed to dealing with a particular regulatory agency can find that changing countries dramatically alters the regulatory strategy and the time involved in gaining approval for a trial.
As the pharmaceutical industry operates on an international basis, it is crucial to understand the manner in which international regulatory guidelines are changing. There is also a great deal of cross-talk between regulatory agencies, which should not be underestimated. Regulatory questions that arise with an agency on one side of the world may appear elsewhere. To provide value to sponsors, CROs have had to become experts in international guidelines so that they can provide advice at the outset of a trial.
An example of how CROs can provide value occurred in May 2004 with the implementation of the European Clinical Trials Directive and its associated legislation. Prior to this date, there had been diverse processes of initiating and conducting clinical trials among Member States, as well as Iceland, Liechtenstein, Norway and other members of the European Economic Area where the Directive is also binding. Many sponsors had become accustomed to the pre-directive era and were frustrated by the impending changes. For CROs, there was no choice but to become as familiar with the new procedures as quickly as possible to advise potential clients.2