Challenges in the Path of Clinical Supplies Process
Clinical trial constitutes an integral step in medical research that is carried out to collect data about the efficacy of a drug and to see whether it is safe for use. These trials can be carried out only after adequate information has been collected. Based on the kind of product and the current stage of development of the product, investigators appoint healthy volunteers or patients into groups, specifically for carrying out pilot studies. Therefore, clinical trials jobs revolve around determining the effectiveness and safety of a new drug or treatment. Clinical trials are becoming complicated these days and the testing often needs to be carried out within a limited time span.
Clinical trial supplies form the critical path bottleneck when it comes to availability and therefore affects the cycle time when it comes to making the product available in the market. A number of tools and practices can be used prior to the trial and during its different stages to make sure that the clinical supply chain is smooth and therefore can be managed more effectively.
There are different challenges that lie in the path of clinical supplies jobs in the different phases namely planning, manufacturing stage and final distribution. During the initial stages of the trials, a standard formula can be implemented to determine the necessary amount that can effectively be used on patients throughout the entire period of study.
A number of things can pose challenges during the planning stage itself. These include the duration of the clinical trials, the availability of patients and their recruitment. Proper clinical trials are dependent largely on the study supplies to different sites so that the drugs prescribed are administered at specific times.
The process of clinical supply manufacturing also faces numerous challenges. These include:
- The necessity to develop small quantities of the product
- The development of different dosage strengths, comparator products and placebos
- Inadequate supply of API or active pharmaceutical ingredient
- Limited expiration date due to the absence of long-term stability data
The distribution stage is also marked by its share of challenges. The shipment needs to be done in compliance with the state specific regulations and therefore distribution of the drug in different countries may pose numerous obstacles. These include:
- GMP regulations and GCP or Good Clinical practices
- An efficient and reliable accountability process in order to ensure that the drugs that are no longer in use can be destroyed, reconciled or returned
- Proper tracking methods to check the various stages of drug development and monitor it to the end-to-end value chain
- Investigator stock control for the sake of complete distribution planning
- Ensuring that the resource material and information is shared amongst all partners
- Making the inventory visible for the sake of distribution planning
A clinical trial protocol comprises a document that is used to acquire a confirmation of the trial design, which needs to be approved by a panel of experts. This is done in order to check that the clinical trial process has been carried out in adherence to the established protocol.
Author Bio: Steven Hayes is a recruitment professional and has been involved in the recruitment of candidates for clinical trials jobs based on their qualifications and industry experience, if any.
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