How to Choose the Right CRO Pharma Partner

Written by on September 23, 2019 in Stuff with 0 Comments
image_pdfimage_print

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.

Tags: ,

Subscribe

If you enjoyed this article, subscribe now to receive more just like it.

Subscribe via RSS Feed Connect on YouTube

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

FAIR USE NOTICE. Many of the articles on this site contain copyrighted material whose use has not been specifically authorized by the copyright owner. We are making this material available in an effort to advance the understanding of environmental issues, human rights, economic and political democracy, and issues of social justice. We believe this constitutes a 'fair use' of the copyrighted material as provided for in Section 107 of the US Copyright Law which contains a list of the various purposes for which the reproduction of a particular work may be considered fair, such as criticism, comment, news reporting, teaching, scholarship, and research. If you wish to use such copyrighted material for purposes of your own that go beyond 'fair use'...you must obtain permission from the copyright owner. And, if you are a copyright owner who wishes to have your content removed, let us know via the "Contact Us" link at the top of the site, and we will promptly remove it.

The information on this site is provided for educational and entertainment purposes only. It is not intended as a substitute for professional advice of any kind. Conscious Life News assumes no responsibility for the use or misuse of this material. Your use of this website indicates your agreement to these terms.

Paid advertising on Conscious Life News may not represent the views and opinions of this website and its contributors. No endorsement of products and services advertised is either expressed or implied.
Top
Send this to a friend