What are the 10 Tips for Enabling Better CRO-Sponsor Collaborations?

By the year 2020, the number of clinical trials being outsourced is predicted to jump to 72% from 23% recorded in 2012.

Even though the alliance between sponsors and CROs is increasing, a client/vendor mentality still exists perpetuating a lack of empowerment and trust.

In the light of these circumstances, experts have provided ten tips to ensure that successful collaborations between the sponsors and CROs are maintained.

First, invest time and mutual effort to learn each other’s culture and language.

Second, agree upon risk mitigation actions to take in advance where applicable.

Third, set escalation parameters at executive, operational, and management levels.

Fourth, define all the business processes as well as the roles and responsibilities of each member.

Fifth, ensure that all members understand how the study progress is being measured and why.

Sixth, set KPIs and risk indicators to handle problems smoothly.

Seventh, align with their partner business goals wherever possible.

Eighth, ensure good communication and management in addition to the automation of activities.

Ninth, encourage their members to have a say in things like monitoring plans, protocol design, etc.

Tenth, enable two-way communication for maximal transparency and constructive feedback.


3 Key Points

  1. Outsourcing of the clinical trials is expected to reach 72% by the year 2020
  2. Despite the increase in the outsourcing trend, problems like a lack of trust and empowerment still exist between the sponsors and CROs.
  3. To manage the sponsor-CRO relationships, there are ten tips to keep in mind

Craig Morgan from Oracle Health Sciences says, “The reality is that the sponsor-CRO relationship is not always a win-win. While sponsors are enticed by the efficiencies that can be gained through CRO use, there is nonetheless a downside to the relationship. The fact is that a sponsor must entrust the study performance to a third party, and that same performance is ultimately the measure upon which the sponsor’s development organization is judged by its senior management.”

Source: https://www.clinicalleader.com/doc/tips-for-enabling-better-cro-sponsor-collaborations-0001

#ClinicalTrials, #DigitalHealth, #ObservationalStudy

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