Clinical trials project management has changed over the years. Over the past decade, one method that has been used more and more is referred to as comparator sourcing of drugs, This practice has become more and more important to the process of developing new drugs, especially for problems that do not currently have great treatments available. When one treatment is undeniably better than the placebo, the other treatment for the condition is considered to be the go to treatment. In comparator sourcing, the new treatment is compares to the this standard.
There are ways to design your clinical trials to make the most of comparator sourcing techniques and methods. Here are some tips to getting the most from your clinical trials using comparator sourcing:
Develop your comparator sourcing long before the clinical trials begin. If you really want to get the most from the clinical trial process and know a big part of that is going to be achieved through the use of comparator sourcing, you need to create a comprehensive plan for this as far in advance as you can. When you devise your plan far in advance, you give your team the maximum number of options and the total flexibility they will need to have a successful clinical trial process. Planning in advance also allows them to identify and deal with risks before they become problems.
Make it a point to nail down all of the details. There is a saying, “the devil is in the details.” This statement cannot be more true than when you are dealing with comparator sourcing for drugs and the clinical trials process. You should start by making a list of all of the details involved in the clinical trials. This list will include items such as the locations (countries, states, cities), the number of places where the trials will be conducted, the length of time of the trials, the dosage information, etc. There are a lot of details in all clinical trials and you have to make sure they are all dealt with.
Be strategic in your thinking. When you are dealing with comparator sourcing, this is not simply a process of procurement. You need to never let the “big picture” fade from your plan. When you are looking at your options and developing the plan for the clinical trials and the drug sourcing, you need to think through the different options that are available. The proper maintenance of the supply chain pharmaceutical products from the start to the end of the clinical trial is incredibly important.
Be careful when you are picking a partner. You need to select a parter who has experience, can be trusted and is well known in the pharmaceutical industry. Ideally, you will find a partner who can offer you fully integrated way to approach the drug sourcing, pharmaceutical packaging and distribution.
- Here are three things to look for with your comparator sourcing partner:How well do they know the location? If you are planning to conduct clinical trials across the planet, you will have to work with someone who knows the different rules and regulations in the different countries. Each area has its own regulatory authorities and procedures. Getting this wrong can end up being very costly.
- How extensive is their network? You need to work with a company has established relationships with other companies so they can get the comparator products at wholesale rates. This will ensure you get the prices you need to lower your expenses and will help prevent any counterfeit drugs from getting into your process.
- How stable are they financially? You need to be sure that your clinical trial material supply will not be hurt by problems with your partner’s financial weaknesses. This is another reasons that your advance planning is so critical to the success of your clinical trials process. You may be able to head off problems with financing early on. This is another way you will be able to keep your costs lower.
The proper planning of any clinical trials requires a lot of advance planning. When comparator sourcing is the method that is going to be used during your clinical trials, the whole process can be a lot more complicated.