How Diligent Pharma Makes Vendor Qualifications More Cost Efficient

Global drug developers spend millions of dollars each year to perform vendor qualifications and re-qualifications. A 2018 study reported that companies spent approximately US $130 to $150 million annually to qualify new vendors – and this did not include re-qualification or personnel costs.1 The importance of vendor qualifications and the associated cost burdens are expected to increase due to several factors:

  • Increasing demand for outsourcing services – The top 10 CROs providing clinical development services grew by 17% between 2020 and 20212, and overall outsourcing demand is expected to increase 9.56% through 2027.3
  • A rising market in decentralized clinical trials – Decentralized clinical trials are introducing more risk that sponsors must manage.4,5,6
  • Growth in innovative technologies – An increasing number of sponsors are using technologies such as artificial intelligence and digital health tools to capture data. 4,5,6
  • Greater complexity in clinical trials – Trial complexity is increasing due to the use of nonconventional elements in the protocol design, larger global scope, and targeted patient subpopulations.7,8

Diligent Pharma can help offset these costs through their standardized approach to vendor qualifications.

  • Enhancing regulatory compliance – Diligent leverages the provider qualification standards developed and maintained by the WCG™ Avoca® Quality Consortium (AQC). WCG Avoca conducts a comprehensive surveillance of the regulatory landscape to develop and maintain these provider standards which helps sponsors avoid fines and delays caused by being noncompliant with regulations.
  • Enabling sponsors to focus on core competencies – Diligent’s technology platform and quality assurance and auditing services allow sponsors to dedicate internal resources to work that provides a competitive advantage.
  • Increasing the line of sight to available clinical service providers – Diligent’s online platform allows sponsors to rapidly search and compare information on over 320 RFIs on 140+ different service providers.
  • Reusing RFI and VQA content – When existing RFI and VQA reports are available, both sponsors and vendors save time and money by not having to repeat qualification activities.

Learn more about overcoming current provider qualification challenges

Complete the form below for instant access to our new research article, Challenges of Qualifying Vendors for Clinical Trials: How Diligent Pharma Streamlines and Accelerates Vendor Qualification. The report offers in depth information on how regulatory compliance can be enhanced through standardization while explaining how trial sponsors can reduce their costs by improving cycle times and managing resources. 

Check the boxes, and we’ll also set up a no-obligation discussion with you about how the Diligent Qualification Platform could help your team and develop some pricing options for you.

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The demand for vendor qualification will continue to grow as companies outsource more clinical development services. However, the high-level regulatory requirements established in ICH GCP E6(R2) and ICH Q10 lack guidance on how to implement these requirements in a fit-for-purpose fashion for individual companies. Trial sponsors as well as service providers invest substantial time and resources to support the high and growing volume of vendor qualifications and re-qualifications each year. The Diligent Qualification Platform offers a new approach with improved efficiencies for both sponsors and providers by using standardized RFI questionnaires and VQA reports to reduce the time and resources needed for vendor qualification. 


  1. Turpen J. Clinical development vendor qualification: “check-the-box” exercise? Contract Pharma. Published March 4, 2020. Accessed December 12, 2022.
  2. Tufts Center for the Study of Drug Development (CSDD). Top CROs gain market share, close record number of M&A deals, improve productivity. Impact Report. 2022;24(6).
  3. ReportLinker. Pharma R&D Outsourcing Market – Global Outlook & Forecast 2022-2027. Published September 2022. Accessed December 12, 2022.
  4. Parkins K, Hillman A. 2022 forecast: decentralized trials to reach new heights with 28% jump. Clinical Trials Arena. Published December 14, 2021. Accessed December 12, 2022.
  5. Lamberti MJ, et al. The impact of decentralized and hybrid trials on sponsor and CRO collaborations. Appl Clin Trials. Published July 27, 2022. Accessed December 12, 2022.
  6. Diligent Pharma. Managing risk in eClinical technologies and decentralized clinical trials (DCTs) [on-demand webinar]. Published May 10, 2022. Accessed November 17, 2022. 
  7. Getz K, Campo R. Trends in clinical trial design complexity. Nat Rev Drug Discov. 2017;16:307. doi:10.1038/nrd.2017.65
  8. Tufts Center for the Study of Drug Development (CSDD). Rising protocol design complexity is driving rapid growth in clinical trial data volume, according to Tufts Center for the Study of Drug Development [press release]. Published January 12, 2021. Accessed December 12, 2022.
  9. Otto C. Prequalification provider assessments shouldn’t be seen in isolation [interview]. Diligent Pharma. Published September 2022. Accessed November 17, 2022.
  10. Tufts Center for the Study of Drug Development (CSDD). Top CROs gain market share, close record number of M&A deals, improve productivity. Impact Report. 2022;24(6).