Clinical strategy teams

Similarly, clinical trial strategy teams bring together CRSs with statisticians, data managers, regulatory executives, pharmaceutical physicians and marketing managers to discuss the clinical data that is needed, and the time-scales and costs, to achieve specific commercial objectives. 

A sponsor of a medical product entering the development phase must have a clinical development plan, which is created by experienced executives and consultants having expertise and experience in the disease state for which the product is intended. Once the plan is created, with appropriate input from regulators, the plan drives a clinical development budget, with consideration of the desired timeframe for projected producf approval. After the plan is created, the management team determines the "make vs. buy" strategy, which determines the elements of fhe plan that will be outsourced. 

Strategies to improve compliance are shown in Table 8. Pharmacists should be encouraged to monitor the use of drugs, to advise on potential side effects and to prevent adverse drug interactions. Nurse-managed clinics improve adherence and outcomes. The other members of the health care team can provide guidance in nutrition or exercise. 

The ICH Q9 strategy and tools can be adapted for a framework for clinical pharmacy, such as described in [5]. The very start of a QRM process is again the description of the work process. As an outcome of their stody the team list a series of decisions that have to be made and specified, for instance by creating SOPs. In this way the priority in creating SOPs is led by the risk analysis. The team realise that QRM may contribute to the protection of the clinical pharmacist who is aware that the risk of patient hazard never can be excluded but who is held to reduce that risk to an acceptable level. 

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