With several pharmaceutical companies starting to engage the services of a CRO pharma, choosing the right partner is a growing concern. Creating the right framework and managing the partnership are two key areas which need to be looked into.
Very often a sponsor will narrowly focus on the metrics instead of a holistic approach all the way through – right from the initial assessment of the outsourcing drivers to the completion of trials.
Assessing Reasons for Partnering With a CRO Pharma
Before entering into any partnership, it’s important to assess the reasons on why this will be beneficial.
The reason could well be that your company could have a capability gap such as data management or monitoring, which prevents the execution of CRO clinical trials.
You may also wish to penetrate a geographical area where you don’t have a presence. Maybe you want to leverage the expertise of a CRO pharma for improving your development plan.
Assessing these and other reasons will influence they way you evaluate and engage into a partnership.
Planning for the Future
Having identified your reasons for setting up a partnership with a CRO Pharma, the next task is to create a vision for the future.
Before getting straight into a negotiation, it is important to have a clear understanding of processes and tasks required for running effective CRO clinical trials.
Getting straight into a negotiation without a thought about the future can lead to conflicts which can be quite frustrating and result in changed orders.
A shared understanding of tasks and processes will set the stage for smooth execution of CRO clinical trials. One of the mistakes to avoid in the initial stage is the assigning of assign ownership of tasks.
This will cause both parties to fall back on their existing processes rather than working to create a new process which is optimised for the trial.
Evaluation Criteria
Once a future vision is set and processes are identified, the next important step is to establish criteria by which the execution of processes will be evaluated. These evaluation methods should include key performance indicators (KPIs).
Evaluation criteria need to be set for the following areas:
Meeting Quality Expectations
The quality criteria for meeting deliverables needs to be clearly set up. Aside from the obvious benefits of meeting quality standards, it necessitates building of preventative measures, deviations and corrective actions in the process.
Including these data points which can be quantitatively measured, gives an objective view on how a CRO Pharma is meeting quality standards. It also minimizes biases resulting from qualitative judgements which tend to occur in the absence of quantitative quality measurement criteria.
Activity Time Cycle
Evaluation criteria should also be set for the time taken to perform different activities.
This is an important criterion when evaluating the performance of transactional and functional service providers. The time cycle criteria should be specific enough to evaluate individuals on their processes.
The purpose is to improve performance standards of those contributing to delays. For example, it’s unfair to penalise a vendor if team members in an organization take too long to review a deliverable.
Timeliness
Criteria for meeting timelines should be clearly set. This is a metric which is of most interest to the leadership team.
A delay in meeting timelines adds to the cost and a delay in bringing the product to market. Speed-to-market is important to gain a competitive edge.
This is one of the primary reasons why senior leaders are focused on meeting times and completion schedules.
Cost Control
CRO clinical trials are getting more complex and costs aren’t the same as they were a few years ago. Costs for CRO clinical trials have to be evaluated individually.
To ensure cost overruns are kept under control, project costs should be constantly evaluated to check for efficiencies and to avoid any misappropriation of funds.
Regardless of individuals who are involved in the process, the criteria should support evaluation of all trials consistently. In addition to this, targets and thresholds should be created for each metric in order to support oversight. Effective action plans must also be put into place outlining corrective measures if thresholds aren’t met.
Selecting a CRO Pharma Partner
Having established processes and set performance levels for a fruitful partnership, potential vendors can now be evaluated.
First, revisit the need for partnering with a CRO pharma, such as geographical need, credibility gap, scaling and others.
Then select CRO Pharma’s which are most aligned to the criteria. Once a shortlist of vendors is established, brainstorm options with them on the best ways to deliver processes. This allows the best options to be uncovered and opening communication lines with potential CRO Pharma partners.
Query potential partners on how they have delivered successful outcomes against your required metrics. Keep in mind that not all the failure or success will be attributed entirely to them.
Also obtain records from potential CRO Pharma partners which demonstrate their ability to meet compliance requirements.
Follow these steps and you will choose a CRO Pharma, you can partner with to introduce new formulations to the market which can help people all over the world live healthier lives.
