Clinical trial services range from the pre-planning stages to post-trial analysis. Other types of clinical trial services include monitoring, regulatory compliance and trial implementation. These trials are conducted to test the effectiveness of experimental treatments and they may lead to the introduction of new prescription drugs.
The first type of clinical trial services relates to the pre-planning stage. These services usually include ensuring that proper paperwork is filed and that government regulations are adhered to. This may involve developing and identifying the goals of the trial and making sure that they fall within regulatory guidelines. It might also include developing screening factors for potential test subjects and making sure that they help identify the best candidates for the trial.
Part of the planning stage also involves developing a trial protocol. It is how the experimental treatments will be administered during the trial. Protocols may also include the number of test subjects that will be given the experimental drug and how many will be given a placebo, which is not an actual drug designed to treat a specific condition. Decisions on whether test subjects will be controlled are also included as part of a protocol, in addition to dosage amounts, frequencies, and drug combinations.
A second form of clinical trial services involves implementation. These types of services help select medical facilities where the trial will be conducted and practitioners that will be involved in administering the treatments. Clinical trial services related to implementation help identify locations, supplies and personnel that are willing to conduct the trial and adhere to guidelines. Considerations such as size, location, quality of care and expertise are taken into account.
Training the medical staff that will be involved in the clinical trial is an important part of the implementation process. Making sure that they are informed about the trial's purpose and how to give out the treatments is part of the training. Besides educating medical practitioners, implementation services also help negotiate payment for the doctors, nurses and test participants, ensuring that the amounts meet the trial's budgetary guidelines.
Study management is yet another important type of clinical trial services. This type of service ensures that the study is going according to plan and maintains compliance with regulatory procedures and guidelines. Data is also collected to compare expectations versus results.
Reporting and analytical services are performed by clinical trial management contractors. As data is obtained from the study and its test subjects, it is entered into clinical trials software that generates reports based upon the study's objectives. Statistical analysis helps determine the effectiveness of the treatment and whether study participants are eligible to advance to other stages that involve further testing of the drug.
