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90% of ClinOps Teams Suffer Needlessly. Here’s Why.

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When it comes to clinical trials, an already rigorous oversight environment has become even more so. With an increasing number of data sources, complexity of protocols and disparate systems, clinical trial teams are finding it nearly impossible to manage it all.  Couple this with the growing need for more sites and countries to power a trial, and you can appreciate the impact to clinical trial management.

Recently, Informa Engage, on behalf of Medidata, conducted a survey to find out from clinical operation teams how the changes in the way clinical trials are structured, set up and executed are impacting them. The bottom line: respondents are overwhelmed with more and more demands and they need help in an increasingly complex clinical trial environment.

90% of respondents said their workload increased as a result of clinical trial oversight, with 30% saying that increase was significant. When asked why the volume of work related to oversight is increasing in clinical trials, top reasons cited were:

  • increasing regulatory requirements
  • more stakeholder and vendor coordination
  • resource constraints
  • workload expansion, and 
  • project complexity

It is clear that sponsors and CROs alike can realize optimal clinical trial management by alleviating these issues. Platform technology, such as the Medidata Rave Clinical Cloud, enable multi-source data ingestion and cross-team collaboration to easily manage even the most complex trials.

The changes that impacted respondents’ day-to-day job the most was being asked to do more with less, patient enrollment challenges and the amount of data needed to be captured and managed. Other strong impacts were seen resulting from an increase in the number of trial endpoints, and the number of additional sites and countries needed to power a trial. 

Stay connected for our next blog that shares how the survey respondents identified operational issues and initiated change.

Survey Statistics

N=135 

Regions

Position

Segments

North America ~50%

Europe 30%

Other 20%

69% in clinical trial operations/development/design

~75% senior directors/managers/c-suite-presidents

CROs 25%

Small BioPharm 20%

 

 

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Jonathan Block

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