Question

You are the head of an R&D department at a major pharmaceutical company. You have five cardiovascular trials to be completed in the next two years. You currently have enough staff to complete the work given no additional changes in project management assignments. Discuss the positive and negative reasons why you would either choose or not choose a CRO to complete the work. Include the types of questions you would need answered to help you make this decision.

Answer 1

ANSWER :-

Positive reasons

1. The most important benefit associated with hiring a Contract Research Organization is that it takes care of the clinical trials that are to be handled by the owner company hiring the CRO.
2. There will be reduction in the costs associated with the manufacturing and the low overhead costs which are associated with the drug in test so that there would be an advantage to the firm to sell the drugs at a low price in a market comprising of different pharmaceutical firms.

Negative reasons

1. Main reason is that in the next two years, there are chances of shuffling of the workforce adding to the burden of the cardiovascular trials and hence acting as a negative reason to hire a CRO.
2. Another factor that should be considered is the turnaround time which in simpler terms can be stated as the deadline or the checkpoint for the clinical trails to be completed. This is turn deals with the quality and the assurance that the product will be of fair quality and will be delivered in time although this can become a problem taking into consideration the multitasking and random infusion of persons involved in the pharmaceutical clinical trials.

Types of questions needed to answer the question to make decisions

1. Will the workforce remain functional after first year of the two years of the clinical trials?
2. How can I lower the cost of the drugs without compensating for the quality of the drug?
3. What will happen if the workforce is being directed to other clinical trials?
4. What will happen if the clinical trials and manufacturing are not completed in time and what alternatives are present?