Imagine yourself in the shoes of a lead clinical investigator or a seasoned product manager assigned to plan and kick off a clinical trial.
Many questions will arise, and you will encounter various obstacles which are not only limited to collecting and organizing datasets and information. But you also need to be well-oriented to disentangle, interpret, and justify your results before proceeding to the next steps.
Most small and mid-size life science companies outsource such contingencies to Contract Research Organizations (CROs) or “Vendors” to plan and conduct all trial-related activities.
Micromanaging such vendors can be an overwhelming process that will hinder your time, judgment, and resources. Your prime concern as a sponsor is not only to supervise all the tasks delegated to the vendor, but you must ensure that all the qualifications, procedures, and trial records are robust, traceable, and complete.
This article will shed some light on vendor management in clinical research and will guide you on how to effectively manage vendors throughout the clinical development process. We will also touch upon a couple of examples of how an eQMS can help you with vendor management and oversight.
SimplerQMS provides a cloud-based eQMS software solution purposefully built for life science organizations to help manage quality management operations, including vendor management and oversight during clinical research. If you are interested in learning more about how our software solution can help you, contact us for a demo.
Now, without further ado, let’s get started!
Feel free to have a look and jump to the sections that you want to learn more about first:
- Reasons for Outsourcing Clinical Investigations
- Regulatory Requirements in Clinical Research
- A 3-Step Vendor Management Process in Clinical Research
- Consequences of Excess Documentation in Clinical Trial & Best Practices
- How SimplerQMS Streamlines Vendor Management Process in Clinical Investigations
Reasons for Outsourcing Clinical Investigations
Vendors can provide niche expertise and resources that may be difficult or costly for sponsors to obtain on their own due to strict regulations imposed by authorities.
In some cases, outsourcing may be the only practical option for sponsors with no internal capabilities or capacity to conduct and manage clinical trials.
Ultimately, partnering with a vendor can help bring new products to market faster and more efficiently.
Therefore, the main reasons for outsourcing clinical investigations are the following:
- Cost reduction. Clinical trials can outcast a devasting blow to the financial stability of many pharmaceutical, biotech, and medical device companies. By outsourcing clinical investigations, sponsors can save on the overhead costs of laboratory space and equipment. It can also help them to reduce the risk of any trial reworks and interruptions by having a trained, experienced, and well-qualified vendor on their side, improving profitability and business outcomes in the long run.
- Patient centricity. Patients are being more involved in the decision-making process when it comes to clinical trial research. With the right vendor expertise, the benefits of delegating tailored research protocols (such as group selection, allocation, randomization, and masking) to vendors can help sponsors to reach a feasible therapeutic endpoint(s), benefitting as many patients as possible, in comparison to the “generalized “and “traditional” clinical research methods.
- Time-saving. Clinical trials can take long as 10 years on average to reach solid ground. Vendors can help sponsors to accelerate the process of bringing new products into the market, by reducing the time and effort needed to conduct research, develop robust research protocols, analyze data, and submit results to the regulatory bodies.
It is a known fact that the complexity of vendor oversight can be prodigious for sponsors, especially if there are multiple vendor(s) involved in handling different segments, related to the same project.
Furthermore, monitoring a vendor’s performance outcome with a manual, paper-based system can be risky and counterintuitive in comparison to an electronic quality management system (QMS), which would allow for a more dependable audit trail and assessment of data.
Quality management solution by SimplerQMS provides the tools that sponsors can use to streamline their quality management processes and monitor clinical vendors more effectively. Moreover, Contract Research Organizations (CROs) themselves can be granted access to help streamline document control and clinical operations.
Regulatory Requirements in Clinical Research
Whether you are conducting a trial for a new drug, medical device, or clinical intervention, many regulatory bodies will govern and regulate your clinical research across multiple regions.
Here are some of the main regulatory requirements that your organization must be fully aware of:
- ICH E6 (R2) Good Clinical Practice
- ISO 14155:2020
- FDA 21 CFR Part 50
- Regulation (EU) No 536/2014
ICH E6 (R2) Good Clinical Practice (GCP)
The document describing ICH E6 (R2) Good Clinical Practices states:
“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects’ participation. Compliance with this standard guarantees that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
This ICH GCP Guideline aims to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
The guideline was developed considering the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO).”
These principles of clinical research have been around for a few decades now and must be followed by sponsors and CROs alike to protect the rights and safety of clinical trial subjects.
The document describing ISO 14155:2022 states:
“This document addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
This document specifies general requirements intended to:
- Protect the rights, safety, and well-being of human subjects,
- Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
- Define the responsibilities of the sponsor and principal investigator
- Assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.”
Even though there might be a lot of overlap between ISO 14155 and ICH GCP, there are some key differences. ISO 14155 is more focused on clinical investigations involving medical devices, while ICH GCP can be applied to clinical investigations of pharmaceutical products.
FDA 21 CFR Part 50
FDA 21 CFR Part 50 applies to all clinical investigations that are conducted with regulated within the jurisdiction of the United States, where it states:
“Investigational New Drug Applications (INDs) are intended for clinical research and marketing permits for products (biologics and medical devices) must be regulated by the FDA. This is to protect the rights and safety of subjects involved in these investigations and to ensure that the outcomes are safe and effective.”
Regulation (EU) No 536/2014
Regulation (EU) No 536/2014 states that:
“In a clinical trial, the rights, safety, dignity, and well-being of subjects should be protected, and the data generated should be reliable and robust. The subjects’ interests should always take priority over all other interests.”
This means that clinical trials conducted in the European Union have to follow certain standards and procedures to protect the rights of clinical trial subjects. The regulation also stipulates that clinical trial sponsors and investigators must take responsibility for the clinical trial and its conduct.
A 3-Step Vendor Management Process in Clinical Research
When clinical research is outsourced to a contract research organization (CRO) or any other type of vendor, the sponsor organization must have a system in place to manage these vendors.
As mentioned previously, an effective vendor management program will help ensure that clinical trials are conducted in accordance with good clinical practices, and will help to protect the rights, safety, and well-being of subjects.
Effective vendor management process can be broken down into three main steps:
- Conducting a Request for Information (RFI) assessment
- Conveying vendor qualification, evaluation, and selection
- Initiating Statement of Work (SOW), Due Diligence, and Service Level Agreements (SLAs)
1. Conduct a Request for Information (RFI) Assessment
The Request for Information (RFI) process is integral to clinical trial vendor selection for every life science company willing to conduct trial-based investigational activities.
The process allows companies to assess the capabilities of any potential vendors by providing a structured methodology to compare vendors. And ultimately make an informed decision that identifies the best fit for their needs.
RFI assessment is used to demonstrate the vendor’s capacity to provide detailed information that is required to provide and deliver any service related to the sponsor’s requirements.
Such requirements can be narrowed down to:
- Could the potential vendor/supplier meet and understand your expected needs and requirements?
- Can the vendor deliver requested services backed by astute track records, portfolios, and experience?
- How does the vendor allocate the quality management system and standard operating procedures (SOPs) within the scope of its operations?
- Are the equipment and facilities validated with proper inspection (Internal and External) records?
- Does the vendor demonstrate solid financial stability that guarantees their commitment to your project(s)?
- Does the vendor go the extra mile to ensure customer service through open and responsible communication?
Although this process can be time-consuming, it is crucial to invest the time to get it right since collaborating with an ill-matched vendor can have serious consequences.
SimplerQMS offers you secure storage for clinical research vendor-related documents, records, and any other pieces of information. Even external documents such as certificates, assessment results, CAPAs, Warning Letters, and Consent Decrees can be stored and easily retrieved whenever necessary.
2. Convey Vendor Qualification, Evaluation, and Selection
The following are the three significant steps that you need to consider in vetting a potential vendor.
Alternatively, you can see the steps visualized in the illustration below.
2.1. Vendor Qualification
Vendor qualification assessment is important to confirm that the vendor can provide the services they have proposed and that the right personnel and infrastructure are fit for your (the sponsor’s) needs.
Additionally, this assessment helps to ensure that any systems or processes that the vendor uses are up to date and meet industry standards.
In the best-case scenario, a well-qualified vendor will declare its services by submitting a request for proposal (RFP).
In this request, the vendor can arguably bid its based services in improving the overall quality of data collected during a clinical trial, reducing the risk of errors, and increasing the chances that studies will be completed on time and within budget.
It is essential to provide all potential vendors with detailed information about your program background, trial design, and desired scope of services. This will help to ensure that bids are comparable and that there is no room for assumptions.
Additionally, it may be helpful to include information such as:
- Description of clinical supplies
- The planned use of electronic systems and devices
- Clinical data standards
- Interim analysis plans
- Any pre-selected countries or clinical sites
Recommended Reading: The Simple Guide to Supplier Qualification in Life Sciences
2.2. Vendor Evaluation and Assessment
Vendor assessment and evaluation are two crucial steps that ensure that the vendor’s personnel, qualifications, experience, and infrastructure are aligned with the proposed services.
It also allows for determining whether there is a cultural fit between the two proposed teams.
A successful clinical study largely depends on the success of the relationship between the sponsor and vendor.
Depending on what is being proposed, risk assessment, and previous experience with a vendor, the qualification assessment may include a remote review or formal vendor qualification audit.
A formal vendor qualification audit is conducted by a quality assurance professional and is a systematic and independent examination of the vendor.
Defining scope is vital before conducting any assessment.
The standard vendor qualification assessment assesses:
- Clinical quality management system
- Privacy policies
- Business recovery plans
- System validation
- Inspection history
A vendor auditing program can help you evaluate a vendor’s performance management process and ensure that the trials are conducted according to protocol and in compliance with applicable regulations. The figure above illustrates the feedback loop between clinical research sponsors and vendors during the vendor evaluation process.
Furthermore, an effective supplier/vendor auditing program can help:
- Identify potential problems or areas of non-compliance
- Improve the efficiency of clinical trials by identifying key performance indicators (KPIs) that enable you to understand and measure the performance of vendors against particular criteria. This allows you to make agile and critical adjustments in your executions towards strategic endpoints.
Defining key performance indicators (KPIs) is critical to effective vendor management in clinical research.
There are several factors to consider when defining KPIs, including the specific needs of your study and the resources available to you.
Some KPIs that could be looked at include the following:
- Cycle time metrics. Time taken for study approval to enrolment, time taken for registering studies and site levels to Regulatory Affairs (RA) authorities, and time taken for studies end to submission time.
- Quality metrics. Number of CAPAs created and resolved, number of planned and unplanned deviations to standard operating procedure (SOP), number of audits with major findings, etc.
- Clinical metrics. Number of studies underway, number of countries in each study, number of sites in each study, number of patients in each phase/study, and so on.
Using a QMS software solution like SimplerQMS you could also generate trending KPI reports on clinical research vendor performance over time. For example, overview the percentage of CAPAs overdue per month, how it compares to the previous month, and the pre-set limit.
2.3. Vendor Selection
Vendor selection kicks off when the sponsor starts assessing and comparing all the KPIs related to all the bidding vendors.
First impressions can sometimes be decisive in awarding a contract.
Therefore, before awarding a contract, it is recommended to conduct bid defense meetings with key personnel who can assess the vendor’s experience and depth of knowledge.
This also allows for determining if a successful partnership will be formed.
It is essential to compare vendor bids based on several factors, including but not limited to:
- Key performance indicators (KPIs)
When assessing KPIs, it is crucial to understand how well the vendor has performed for previous clients.
Therefore, one KPI that may be considered is the vendor’s record for achieving agreed timelines. But not just the standard cycle time target, such as the enrollment period.
The historical performance information provided by potential vendors should be specified in the RFP so that there is a standardized way to compare vendors’ performance track records.
Additionally, when assessing cost, it is essential to ensure that the underlying assumptions are comparable. Many less quantitative attributes can impact vendor selection, such as whether the vendor seems enthusiastic about the project or has provided valuable insights through the RFP process.
The agenda at bid defense meetings should include an in-depth discussion on outsourced activities with assumptions, critical quality attributes, timelines, and the sponsor’s planned approach to vendor management and oversight, where you must:
- Invest in a positive sum mindset that effectively builds strong relationships with your vendors.
- Implement a win-win approach that will guarantee that your potential vendor is aligned with business goals, vision, and code of conduct.
By doing such crucial gestures, you will take the initiative in establishing clear communication channels and protocols with your vendors, addressing problems are they occur, and preventing any hindrance to the overall outcome of your project.
By taking the time to research a vendor’s past performance, you can make a more informed decision about whether they’re the right fit for your organization.
SimplerQMS offers an all-in-one cloud-based eQMS system with various vendor quality management features. The system allows you to select, evaluate, qualify, and track vendors against pre-defined KPIs. Award contracts, maintain an approved vendor list, and get notified when a vendor needs evaluation and recertification – all within one system.
3. Initiate Statement of Work (SOW), Due Diligence, and Service Level Agreements (SLAs)
Once a vendor has been selected, and before setting everything into motion, a Statement of Work (SOW) and a Service Level Agreement (SLA) are important documents that should be created when two parties enter a business relationship.
The SOW outlines the specific services that will be provided by the vendor, while the SLA establishes expectations for service quality and performance.
Having these documents in place helps to ensure that both parties understand their roles and responsibilities and can help avoid potential conflicts down the road.
The importance of a well-crafted service-level agreement (SLA) cannot be overstated. Taking the time to create a comprehensive and transparent understanding is crucial to ensuring all parties are satisfied with the terms of the contract.
That is why it is highly recommended to engage an experienced individual in vendor contracting and negotiations to avoid costly vendor change orders down the road. In addition, taking the time to identify cost drivers early on may help prevent changes that need to be made later in the trial design or conduct. Also known as the identification of “nice-to-have” versus “must-have.”
The contract should also include a description of circumstances under which it could be terminated for non-performance.
However, it is generally not advisable to quantify these criteria (e.g., missing the first patient in the timeline by a specified number of weeks).
Instead, the contract should reference specific performance characteristics that would warrant termination of the agreement. Such as consistent failure to meet SLAs or poor-quality monitoring as documented by audits.
Moreover, many small-to-mid-sized biotechnology companies do not have a data-driven approach when estimating their initial trial budget. Instead, they often rely on “per patient” costs which are usually inaccurate.
This lack of an accurate budget estimate can then impact other areas, such as financial forecasting and anticipated fundraising needs, as well as the sponsor’s ability to assess vendor bids.
Fortunately, with SimplerQMS you can provide relevant evidence and record tracing during inspections and regulatory audits, where you can track and retrieve all SLAs, and other documents when needed. With its custom-built reminders, you can schedule, plan, and review all supplier-related activities, hyperlink vendor certificates, audit findings/non-conformances, and issue CAPAs when necessary.
Consequences of Excess Documentation in Clinical Trial & Best Practices
Although documentation is a critical part of clinical trials, excess documentation remains one of the vital key risk indicators that encumbers many sponsors.
Excess documentation can cause delays in the trial process and may result in data being lost or misplaced. It can also lead to errors in the data, which can invalidate the trial results.
In addition, documentation can be costly and time-consuming for both sponsors and vendors on the investigational site.
While it is crucial to have adequate documentation, it is also essential to strike a balance so that clinical trials can run smoothly and efficiently.
There are several regulatory requirements for document control in clinical trials and ensuring compliance with them can be challenging.
Here are some best practices for staying on top of document control in clinical trials:
- Establish a clear and concise document management plan at the outset of the trial. This plan should outline how documents will be created, tracked, and stored throughout the course of the trial.
- Assign responsibility for document control to a committed team or individual. This person or group should be responsible for maintaining an up-to-date master file of trial documents and promptly ensuring that all documents are correctly filed and indexed.
- Implement strict controls on who can access and modify trial documents. Access should be limited to only those who need it, and all document changes should be carefully tracked and monitored.
- Store all trial documents in a secure central repository. This will help ensure that all documents are accessible by authorized personnel, ensuring no unauthorized amendments are made.
- Make sure all staff involved in the clinical trial are trained on proper document control procedures. This will help ensure that everyone understands their role in maintaining accurate and complete documentation for the trial.
How SimplerQMS Streamlines Vendor Management Process in Clinical Investigations
There are many reasons why using a quality management software solution like SimplerQMS is better than manual document processes, especially when clinical investigations are concerned.
First of all, it allows you to automate many of the tasks involved in document processing, saving you a lot of time and effort. Additionally, the system keeps track of your documents more effectively, ensuring that they are organized and accessible when you need them, eliminating the need for paper and other physical storage materials.
Furthermore, SimplerQMS provides a secure central repository for all your documents, so you can be confident that they are safe and sound. Its straightforward interface will equip you with a state-of-the-art document control solution with trackable version control that ensures that only the most up-to-date documents are present.
Lastly, and arguably most importantly, clinical research vendors can be granted a special license with controlled access to the SimplerQMS system to help ensure ownership of the data, and streamline documentation processes. This allows your vendor to help keep the data organized and up to date while also simplifying any documentation that needs to be done on their end.
This also adds an extra layer of protection and security to the clinical trial process, giving sponsors more peace of mind.
Considering the complexity of today’s world, where you are in one region and your vendors are in a different region of the globe, it becomes essential to have an effective vendor management program in place.
This is not only important in terms of customer satisfaction and enhanced brand value but also a core responsibility since international regulations, guidelines, and standards expect this.
Investing in an efficient Quality Management Solution like SimplerQMS can help streamline vendor management processes and make compliance with current regulatory requirements easier.
To learn more about how SimplerQMS can help your business, book a personalized demo with our experts today and allow us to help you excel in quality management within your organization.