IN PARTNERSHIP
vendor offers all the capabilities that the trial will need. These may include subject management, inventory management, site management, user management and configuration options. Look for software that allows assigning
roles that limit the ability to view and edit only the screens and activities pertaining to the individual’s job; this is helpful to both simplify tasks and prevent errors.
Financial terms and organisational support The RFP response should be clear on what is included in the project and what could be added at an additional cost; for example, optional modules or any custom coding that may be needed. Depending on a CRO’s needs, a modular system
that allows it to choose the capabilities it needs and only pay for the modules it uses may be the most cost-effective option. Some other areas that might impact the total cost include how start and stop dates are defined, how flexible the vendor is if the study is postponed or cancelled and what costs are incurred if change orders are needed. Who will support the team is as important as the IRT system itself – look for experience, training and level of assistance. For example, if the trial will be conducted in multiple countries, look for an organisation that has supported many international clinical trials. In addition, the RFP response should specify the type of training and support expected.
The critical start-up phase A good IRT partner has the knowledge to guide a team through a start-up that is quick, efficient and successful. By leveraging their specialised experience, the IRT partner can save time by advising on specifications and the necessary steps to document and set-up the trial, so the milestones aren’t missed. A comprehensive process will likely start with a
master service agreement (MSA). The MSA is like an umbrella agreement that lays out expectations for working together, preventing misunderstandings that could cause lost time during the project. The MSA further clarifies the financial terms, warranties and confidentiality needed. This is key for transparency and a smooth-working relationship. Once the MSA is in place, it can also be used
for subsequent projects, which will save time. The next step is to quickly complete the service order
(SO). This is an agreement specific to the project and contains items such as the set-up and modules that will be used, the monthly maintenance fee and milestones. An ideal IRT system partner will build a good
working relationship during the entire course of the study. They’ll start by assigning an experienced, dedicated project manager (PM) and backup PM to the project. The PM is the primary contact and works with the CRO to determine the specifications of the project, creates the user requirements specification (URS) and acts as the ‘champion’ throughout the project’s life. The PM will initiate a kick-off meeting to
introduce team members, clarify roles and responsibilities, and explain processes for obtaining the subject randomisation, clinical trial material lists and information gathering for the user requirement specification. After the requirements are gathered, the developer will programme the first build. The first build should be demonstrated and reviewed with the team, who may suggest minor changes. The IRT system partner should also provide the
team with a validation summary report (VSR) so any issues during validation can be reviewed. A thorough VSR will display the errors found. The more thorough job the validation team does, the smoother the CRO’s own testing will be. It is much better if the validation team finds and fixes the errors before its team does, which will save time during user acceptance testing.
Training and support The IRT partner should provide training and support at the beginning and all through the process, guiding every step of the way. Even if the chosen partner has a system that is easy to use, some questions will arise, and changes will be needed. As the study progresses, the IRT system and team should be able to make data and configuration changes quickly and effectively to keep the clinical trial on track. As clinical trials often run in multiple time zones, help should be available 24/7, via email and phone. IRT solutions can make many aspects of the clinical trial process faster and more efficient. Choose wisely, as the partner with the team and tools that best fits the CRO’s needs will make a positive impact on running its clinical trials. ●
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