The Elements Needed to Avoid Risks in Clinical Trials

The Elements Needed to Avoid Risks in Clinical Trials

Falsified medicines directive

Drug developers are working to address the issue of drug sourcing in order to change the way that clinical trials project management is done. this is important because there is a lot of pressure surrounding the development of medical supplies and medicines trying to get them to be better that the treatments are currently available. Managing drug sourcing is a lot more complicated than it sounds because many clinical studies are done in random locations and weaknesses in the pharmaceutical supply chain management practice. There are four main areas that must be address if you want to make drug sourcing a lot more manageable. They are as follows:

Getting Ahead of the Game:
Drug sourcing should begin in the planning stages, even before the clinical trial starts. Protocol development strategies must be in place in order to maximize flexibility and other options so that risks can be better identified. This is probably one of the easiest ways to reduce the risks because it allows for a number of things beside maximizing flexibility:

  • Evaluates variations from comparators like dosage and strength as well as packaging and presentation.
  • Reviews options for sourcing as far as regulations are concerned.
  • Evaluates price versus the cost.
  • Confirms documentation.

Listing the Facts:
It’s important to identify the relevant facts about the details of the clinical trial. This includes countries, sites, subjects, length of time, strength and top volume of the comparator. These things are all needed in order to be able to predict what the clinical trial material supply needs will be and conduct whatever planning is needed to reach the best solution.

Starting to Think Strategically:
Sourcing to clinical trials is more than just make a purchase or procuring the drug. A strategic approach means needing to see the big picture in order to take into account every factor and create a plan that is custom made for that particular situation complete with other options. The main goal is to manage the supply chain from the day the trial starts all the way through until it finishes.

Selecting a Partner:
Your partner needs to be well known, trust worthy and have plenty of experience. When conducting a clinical trial, the fewer people that have hands on methods, the better. Including drug sourcing, packaging services, labeling and also distribution. This will make the process a lot more efficient as far as time and money goes. Selecting a partner can mean developing a supply agreement with a connection. Although, most sponsors prefer to stay anonymous during the course of the sourcing process so this doesn’t always work. If a sponsor does want to maintain that anonymity they can leverage direct sourcing route by selecting partnership with a specialist that has relationships with the manufacturers and has the ability to negotiate on the sponsor’s behalf so that the manufacturers do not feel like the anonymity is a risk they may not be willing to take.

These clinical trials for new drugs are not yet the common method of testing. They are mainly used when a manufacturer wants to prove that one drug is better than another. Either that or when the use of a placebo would not be considered ethical during testing. Usually, a drug will be compared to a placebo during clinical trials but for these, the drug is being compared to the already existing treatment. That is why they can be so risky.

Part of the problem is that any kind of exposure to operations, regulators and finances can increase the risk factor is sourcing is looked at as a series of transactions instead of a process that has been developed through a well planned strategy.

Comparator drug sourcing needs to be though of as a crucial strategic part of the planning and preparation for any kind of clinical trial. A procurement team should have certain goals in place including finding out about the timing, volume needs and geographic regulations as well as how much time is necessary in order to effectively evaluate any sourcing options. The procurement team and the clinical team should have close and open communication that will allow for early planning in any given area of the trial in order to reduce the exposure to risks and unexpected costs.


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