Vendor Horror Stories – Conference Recap

Welcome back to the Mayet blog! As proud sponsors of this year’s Institute of Clinical Research Ethics and GCP Forum, we had the unique opportunity to engage directly incredible community at the forefront of clinical trials.

A special thanks to the Institute for hosting us, to UCL for providing a fantastic venue, and to the outstanding efforts of organisers like Trish Parry, Karen Roy, Helen Buck, and Helen Cadiou, who made this event a success.

During our Lunch Time Exhibit, we not only connected with industry peers but also launched an exciting contest that became the highlight of our participation: attendees were invited to share their most distressing vendor management experiences.

In this blog post I review and analyse come of the “horror stories” collected during this event, these insights aim to transform daunting challenges into opportunities for growth and improved outcomes in clinical trial delivery.

Story 1: A Tangled Web of Miscommunication

The Nightmare Begins:

“Our journey with a CDMO for a phase 1 study started with securing a £800,000 budget for IMP manufacturing. However, a year into the partnership, internal miscommunications plagued progress. Handover lapses between the business development manager and the technical team led to confusion and project delays. Despite heavy reliance on our approval for documentation, the CDMO offered minimal support, leaving us liable for any mishaps. To salvage the situation, we had to enlist a regulatory consultant for additional assistance in navigating discussions. Ultimately, this ordeal was marred by poor communication and a lack of clarity regarding expectations.”

Detailed Analysis of Root Causes:

1. Inadequate Handover Processes: The transition between business development and technical teams often lacks a formalised procedure, leading to vital information being lost or misinterpreted. This gap can derail project timelines right from their inception, causing setbacks that are hard to recover from without significant effort and resource allocation.
2. Insufficient Support and Guidance: When CDMOs fail to provide adequate support, particularly in navigating the complexities of documentation and compliance requirements, it places an undue burden on the sponsor. This lack of support can lead to compliance risks, delayed timelines, and increased costs due to potential regulatory issues.
3. Unclear Communication Protocols: Without predefined communication standards and expectations, interactions can become inconsistent and inefficient. This often results in misunderstandings and a reactive rather than proactive approach to problem-solving, compounding delays and frustrations on both sides.

Strategic Opportunities for Improvement:

1. Implement Structured Handover Procedures: Establishing a systematic handover protocol is crucial. This should include detailed documentation of all critical project aspects and mandatory briefing sessions to ensure all team members are on the same page. Such procedures will ensure continuity and consistency, reducing the risk of miscommunication and enabling smoother project progression.
2. Establish a Comprehensive Support Framework: Creating a robust support system involving regular updates and designated contacts at the CDMO can enhance the guidance provided to sponsors. This framework should not only address routine queries but also offer strategic advice and proactive solutions to potential challenges, thereby fostering a more collaborative and supportive partnership.
3. Develop Clear Communication Protocols: Clear, agreed-upon communication protocols must be established from the start of the partnership. These protocols should include regular check-ins, scheduled updates, and predefined escalation paths for addressing issues promptly. Additionally, setting clear project milestones and regularly reviewing them allows both parties to stay aligned and make necessary adjustments in a timely manner.

Story 2: A Breach of Trust and Protocol

The Nightmare Begins:

“As a QA auditor for a CRO, I asked an IT service provider to show their SOPs on how they trained their team members. They refused. The head of QA in our organisation responded that this was fine as our IT manager knew the provider very well. However, when the CRO changed process to give IT access to different staff members of external auditors, the IT service provider was sent the new process and forgot to train their staff, and did not respond to our offer to train them. This resulted in an error giving access to key staff. A month after, the CRO was subject to a GCP inspection from the regulator and the event titled “Lack of Oversight” from the CRO to the service provider resulted in a Major Finding.”

Detailed Analysis of Root Causes:

1. Over-reliance on Informal Relationships Over Formal Protocols: This common issue often emerges from long-standing partnerships where comfort and familiarity lead to a laxity in formal engagements. The risk here is that key process information remains undocumented and unenforceable, relying instead on personal assurances which are not sustainable or scalable, particularly as organisations grow or experience turnover.
2. Inadequate Response Mechanisms for Training and Updating Processes within the IT Service Provider: Often, IT service providers operate with set protocols that may not be immediately adaptable to client changes unless explicitly reconfigured. Without a proactive approach to training and updates, these providers can become bottlenecks, unable to pivot or scale according to the evolving needs of the clinical trial sector.
3. Insufficient Oversight and Verification of Vendor Compliance to New Processes: Without rigorous oversight practices, it’s challenging to ensure that vendors consistently adhere to updated procedures. This gap can lead to compliance risks, especially under the scrutiny of regulatory bodies. It highlights a need for a more structured approach to monitoring vendor activities and ensuring that changes are implemented effectively.

Strategic Opportunities for Improvement:

1. Establish Mandatory Disclosure of Training SOPs for All Vendors as Part of the Vendor Management Protocol: By making the disclosure of Standard Operating Procedures (SOPs) mandatory, organisations can enforce a standard of transparency and accountability. This requirement helps ensure that all vendor staff are appropriately trained and that their training is documented, reducing the risk of errors due to insufficient knowledge or preparation.
2. Create a Robust Change Management Process that Includes Training and Verification for All Updated Procedures: Developing a change management process that is both robust and inclusive is crucial. This process should encompass not only the initiation of changes but also the training, implementation, and verification stages. Regular updates, accompanied by thorough training sessions and assessments, ensure that all parties are on the same page and that the implemented changes achieve their intended outcomes.
3. Enhance Oversight Mechanisms, Including Regular Audits and Checks, to Ensure Vendor Compliance with Agreed-Upon Standards and Processes: Strengthening oversight mechanisms can significantly improve compliance and performance. Regular audits and compliance checks should be scheduled, not just as a formality but as an active measure to engage with vendors and address potential issues proactively. This approach not only reinforces the importance of compliance but also helps build a culture of continuous improvement and accountability between the vendor and the clinical trial sponsor.

Story 3: System Failure and Lack of Proactivity

The Nightmare Begins:

“We are a CRO currently working with an electronic patient reported outcome (ePRO) vendor and have had the following problems with their services:

• Questions not completed showing as complete on the electronic participant surveys
• Language translation facility not working properly
• Questions stopping spontaneously
• Poor proactive feedback from the provider and slow tackling of issues by the vendor project manager
• No adaptations made to the tablet for specific jurisdictions to use the tablet.
  And many more problems”

Detailed Analysis of Root Causes:

1. Technical Glitches and Inadequate System Testing Before Deployment: Often, ePRO systems are rushed to launch without comprehensive testing, leading to malfunctions such as data errors and system crashes. This can severely impact trial data integrity and participant compliance.
2. Ineffective Communication and Feedback Mechanisms: A disconnect between the CRO and the ePRO vendor can result in unresolved issues and repeated errors. Poor communication slows down the resolution process, leading to frustration and potential compliance risks.
3. Lack of Customisation and Local Regulation Consideration: ePRO systems that are not tailored to specific trial locales may fail to meet local regulatory requirements or cultural needs. This oversight can lead to legal issues and hinder participant engagement.

Opportunities for Improvement:

1. Implement Rigorous Pre-deployment Testing and Validation Protocols: Establish a standard procedure for multiple rounds of testing that includes scenario-based and stress testing to ensure the system’s robustness and reliability. Involvement of end-users during the testing phase can provide valuable insights and lead to early detection of potential issues.
2. Establish Proactive and Transparent Communication Channels: Create a structured communication plan that outlines regular check-ins, update meetings, and designated contacts for immediate concerns. This should include a feedback loop that allows for quick adjustments based on user experience and vendor insights.
3. Develop a Customisation Framework: Introduce a flexible system design that can easily be adjusted to meet the specific needs of different jurisdictions. This includes language options, regulatory compliance adjustments, and local data handling requirements. Ensure that the framework is designed to accommodate updates as regulations change over time.