Strategic Roadmap for Successful Seasonal Influenza IVD Clinical Trials

Point-of-Care (POC) diagnostic trials for influenza are unlike any other. The season is short, virus circulation is unpredictable, and enrollment targets — particularly for influenza B — are notoriously difficult to meet. Every week counts, and missteps in site startup, patient access, or data flow can jeopardize an entire program.

At Beaufort, we’ve built our approach to meet these challenges head-on. We deliver end-to-end CRO services with proven expertise and proactive strategies that simplify complexity and safeguard timelines. Our team integrates rapid site activation, flexible patient recruitment, streamlined vendor oversight, real-time data management, and inspection-ready quality systems — ensuring sponsors capture the season and achieve submission-ready results.

Strategic & Targeted Patient Access

Meeting enrollment targets in an influenza in vitro diagnostic (IVD) trial requires a precise understanding of seasonal influenza patterns and a proactive, flexible approach to sample collection. Beaufort applies strategies that enable rapid site activation and maximize subject participation during peak influenza circulation through:

Enrollment success depends on activating the right sites at the right time — and that’s where Beaufort excels.

Development of a seasonally aligned, high-throughput, and geographically diverse enrollment plan supported by real-time monitoring of influenza positivity rates and contingency strategies to ensure sufficient influenza B cases.
Definition of clear inclusion criteria based on influenza-like illness (ILI) symptoms and prioritization of high-volume, high-performing sites such as urgent care centers, outpatient clinics, and pediatric practices to accelerate trial startup.
Application of flexible and nimble enrollment processes enabling sites to rapidly identify, consent, and collect samples from eligible patients, ensuring timely completion of enrollment within the influenza season.

Streamlined Trial Operations & Delivery

The seasonality of influenza, coupled with complex logistics and vendor coordination, demands efficiency and adaptability. Beaufort structures its delivery model to keep specimen flow uninterrupted, vendors aligned, and monitoring optimized throughout the influenza season by:

Deploying a full and experienced trial team at launch to ensure rapid scale-up ahead of peak influenza circulation.
Harmonizing vendor and laboratory oversight with a dedicated manager streamlining contracting, specimen handling, and testing logistics.
Optimizing clinical monitoring and site oversight for timely verification of enrollment data, sample integrity, and rapid issue resolution.
Building a streamlined data management framework with standardized processes, real-time data reconciliation, and rapid cleaning of laboratory and clinical data streams.

Continuous specimen flow is the difference between meeting timelines and missing the season.

Together, these measures shorten startup timelines, maintain uninterrupted specimen flow, reduce operational bottlenecks, and accelerate data readiness — all essential to executing influenza IVD trials within the narrow seasonal window.

Relentless Quality Assurance from Day One

Quality and compliance are safeguarded from the very beginning. Beaufort implements measures that protect data integrity, ensure inspection readiness, and keep the trial financially on track at every stage:

An inspection readiness program is launched from the start.
Data quality standards are implemented across clinical monitoring and data reviews.
Customized visual dashboards are designed to track site progress, compliance, and key milestones.
Financial project analysis is conducted to detect, report, and mitigate potential budget variances.

These quality assurance measures reduce operational risk, minimize data cleaning burdens, prevent compliance setbacks, and keep the trial financially stable — increasing both efficiency and confidence in delivering influenza IVD trials within seasonal timelines.

Results that Meet Your Needs

Beaufort’s integrated approach to patient access, streamlined delivery, and relentless quality assurance ensures the successful execution of influenza IVD trials in seasonal respiratory infection:

Enrollment targets are met on schedule, with a seasonally aligned and geographically diverse plan.
Rapid site activation and flexible recruitment processes accelerate enrollment, ensuring timely completion within the influenza season.
Real-time monitoring and proactive data management accelerate interim analysis delivery and maintain continuous visibility of site performance.
Inspection readiness and compliance programs safeguard regulatory preparedness, while standardized quality measures reduce the incidence of data queries and increase protocol compliance rates.
Proactive financial oversight keeps the trial on track, with early analysis mitigating potential budget variances.

Seasonal Trials Move Fast. So Do We.

This integrated CRO services model reduces delays, prevents bottlenecks, and accelerates both enrollment and data readiness, ensuring influenza IVD trials are completed efficiently within the narrow seasonal timeframe Let’s talk about how Beaufort’s CRO services can accelerate your influenza program and deliver results on time. Contact Us Today.

Authored by: Trish Landry
SVP, Global Clinical Operations

Planning a clinical trial for medical devices, including in vitro diagnostics (IVDs), is a complex, multi-faceted process that requires strategic thinking, careful preparation, and foresight. According to industry data, nearly 30% of clinical trials fail to secure regulatory clearance or approval, often due to inadequacies in trial design, data collection, or regulatory alignment. Additionally, up to 80% of clinical trials face delays or cost overruns, primarily because of insufficient planning in areas such as subject recruitment and risk management. To help avoid these pitfalls and improve your chances of success, here are some key considerations when planning your next clinical trial.

1. Engaging Early and Often with Regulatory Authorities

There are a multitude of considerations and influencing factors that inform both regulatory strategy and study planning for your product development. To help your trial start off on the right track and meet all necessary requirements, ongoing communication with regulatory bodies is essential. In the U.S., leveraging resources like the FDA’s pre-submission process can clarify performance expectations and help align your trial with regulatory requirements. Early engagement reduces the likelihood of having to make significant adjustments late in the trial process. Regular interaction helps to address concerns before they become roadblocks. Beaufort has extensive experience partnering with sponsors who rely on our expertise navigating regulatory complexities.

2. Conducting Thorough Feasibility Studies

Clinical feasibility studies can identify potential issues with your trial design before investing time and resources on a full trial. By designing relevant and appropriate feasibility studies, you can ensure that your timeline is realistic, that the site(s) selected meet the needs of your trial, and that the trial design is viable. By evaluating the constraints your clinical trial will have on a smaller scale, you can preempt issues that can commonly occur during trial execution.

3. Risk Management and Contingency Planning

Clinical trials often face unexpected challenges, such as subject recruitment delays, supply chain disruptions, product design changes, or regulatory setbacks. Incorporating a proactive risk management strategy and developing contingency plans are crucial for minimizing the impact of these issues. Our team’s extensive risk management experience can help you rigorously evaluate, refine, and implement risk management activities that prepare you for common obstacles, keeping your trial on schedule and within budget.

4. Developing a Robust Protocol

A clear, detailed protocol is essential to a successful clinical trial. It ensures that investigators, sponsors, and other stakeholders are aligned on their roles and responsibilities, as well as ensuring consistency in execution. Having a transparent, clear protocol will minimize the potential for misunderstandings among stakeholders and also with regulatory authorities.

5. Prioritizing Site Training and Support

Comprehensive site training and supporting trial sites are essential to your success. Extensively reviewing with site personnel the specific requirements for handling devices, collecting data, or processing specimens is critical. Regular communication and support ensure consistency and adherence to trial protocols, and potentially minimizes the risk of errors and deviations.

6. Comprehensive Monitoring

A robust Monitoring Plan guides the project team to monitor your trial properly, maintaining participant safety and data integrity. Effective monitoring ensures that the protocol is being followed and allows for early detection of issues, increasing operational efficiency. The monitoring process also enhances communication between sponsors, investigators, and sites, providing an opportunity for a quick resolution to any issues and reinforcing alignment with the overall goals of the trial. By focusing on protocol adherence and proper documentation, sponsors and sites are better prepared for potential audits, and eventually regulatory inspections.

7. Investing in Strong Data Management

For medical device trials that generate large volumes of complex data, effective data management is vital. Data must be securely and accurately collected to preserve quality and validity. Implementing robust electronic data capture (EDC) systems and adhering to Good Clinical Practice (GCP) standards will minimize errors and ensure compliance. Beaufort’s data sciences team is able to design custom data management solutions to fit your trial, maintaining the integrity and security of your data across the entire trial.

8. Leveraging Technology for Trial Optimization

The use of advanced technologies like AI, machine learning, and automation is becoming increasingly embedded in the clinical trial management process. AI-driven patient recruitment tools and predictive analytics can improve trial efficiency, while automation in data collection reduces human error. Tools such as wearable trackers and telehealth are developing quickly to meet the needs of decentralized trials and remote monitoring. Utilizing these technologies can help streamline processes, reduce costs, and increase the likelihood of regulatory success.

Successful clinical trials for IVDs and other medical devices require thoughtful planning and execution. By taking these key considerations into account, sponsors can significantly improve the chances of regulatory success, stay within budget, and complete clinical trials on time.

At Beaufort, we have extensive experience guiding sponsors through the complexities of trial planning and execution. Whether it’s navigating regulatory pathways, optimizing trial design, site recruitment and management, or ensuring data integrity, we can help you successfully manage your next clinical trial from start to finish.

Learn more about our comprehensive Clinical Trial Services & Solutions or Contact Us today.

A key and distinct characteristic of IVD clinical studies is that they are conducted on samples taken from study participants. Patient samples may still be used in other types of studies, for example, to show drug concentration in the blood during a pharmaceutical study; however, for IVD clinical studies, analysis of the patient sample is the source of the primary data set supporting your device’s clinical performance in a regulatory submission.

Due to the criticality of the patient samples, a sample management approach that clearly demonstrates appropriate sample handling as well as a well-documented audit trail is of the utmost importance. In an IVD clinical study, samples that are misplaced, mishandled, or otherwise invalidated will have an impact on timelines, budget, and data integrity – which could jeopardize your entire study.

Strategic Sample Management

Successful sample management starts early by clearly defining in the study protocol how you plan to maintain sample integrity. The more clearly defined and articulated practices that are in place supporting sample management, the better your chances are of being able to provide a complete, documented record of the sample journey and chain of custody (CoC).

All sample management strategies have three primary points during the sample’s journey where well-defined processes and parameters are needed:

sample collection
sample processing
sample transportation and storage

The sample management strategies you decide on will vary based on several factors, including the target analyte, the sample type, and the intended use setting.

The sample management strategies you decide on will vary based on several factors, including the target analyte, the sample type, and the intended use setting. Due to the range of intended use settings for IVDs, there may be additional analytical testing requirements to support sample stability and collection parameters. IVDs also have a wide array of common sample types with differing collection, processing, and handling intricacies.

Beaufort has deep expertise in working with diagnostic sponsors from the early planning stages of your study to ensure that the choices you make will help ensure proper sample handling and study success.

Adapting to Use Settings

It is important to consider the intended use setting. Is this a point-of-care device where the turnaround time from sample collection to testing will be minimal? If so, additional analytical testing supporting analyte stability for the sample in ambient storage conditions may be required in order to ensure the sample is processed before any impact to integrity of the sample (and thus the data) occurs. Are you developing a home test in which the patient collects the sample then ships the sample for testing at a central lab? Then freeze/thaw data and sample shelf-life data may help guide shipping specifications, in addition to sample collection instructions for the home user. The IVD risk classification and intended regulatory pathway, as determined by the device’s intended user and intended use setting, can be used to inform decisions about the data needed to support sample management in the clinical study protocol.

Diverse Sample Types and Handling Requirements

A variety of sample types, such as nasal swabs, nasal wash, blood, and tissue, are used in IVD clinical studies. These samples may be collected prospectively or retrospectively or may be purchased from sample banks or well-characterized cohorts. Further, samples may be impacted by conditions such as hemolysis, lipemia, or bilirubin interference during collection. It is important for the protocol to clearly articulate the source of the samples as well as appropriate collection techniques and materials, including the quantity and quality of sample needed. Questions to consider addressing in your protocol could include:

What transport media are acceptable?
Will samples be collected under informed consent prospectively for the study or purchased from a sample bank?
What size blood collection tubes should be utilized to collect the necessary blood volume for testing?
How soon after collection should samples be processed before testing or shipment?
Will a sample with hemolysis affect your analyte results?

As sample contamination could have major effects on test accuracy, precautions should be taken during sample collection to ensure samples remain free from contaminants. Samples that may be biohazardous will warrant extra precautions, and it is advisable for these to be well-documented in the protocol and emphasized during training.

Labeling Protocol Considerations

Proper specimen labeling at the point of collection is a critical process to define in your protocol. Misidentified or inadequately labeled samples are a major source of sample management failures, so having clearly communicated expectations for sample labels can help protect the integrity of your samples and data. A typical label would include the protocol number, a site and subject identifier, and a unique identifier for that sample.

In some cases, it is desirable to collect enough sample to divide into multiple aliquots that can be tested, shipped, and stored for future use. In this case, the label should indicate the aliquot number of the sample or if it is a paired sample (i.e., Swab 1 of 2). Handwritten labels are not advised. The labels should also be durable enough to withstand expected storage conditions. For example, labels should remain adhered at -80°C or colder if samples are to be stored in an ultra-freezer. Likewise, samples that might sit in an ice or water bath should be waterproof. It is important for study sites to be provided with appropriate sample collection materials (including sample labels), and all expectations regarding labeling and documentation of all samples and sample types should be emphasized and understood.

Aligning Site Capabilities with Protocols

The procedure for collecting samples should be clearly and comprehensively articulated in your protocol and part of study training. Regular communication with your sites will also increase protocol adherence, as will employing robust, frequent quality control processes.

Partners with IVD expertise are better equipped to comprehend the nuances of the IVD protocol and ensure that the documentation requirements are met….

Working with established sites with proven competence, as well as utilizing monitors that are experienced with the nuances and intricacies of IVD sample management, improves the sample integrity you can expect during your study. Partners with IVD expertise are better equipped to comprehend the nuances of the IVD protocol and ensure that the documentation requirements are met to provide traceability into the sample handling and chain of custody.

Depending on your intended use setting and your investigational product characteristics, sample processing could happen immediately upon collection, or samples could be sent to a central lab for evaluation. In addition, site capabilities, processes, and procedures must line up with protocol requirements.

Ensure that your clinical study testing sites have the proper equipment and that any equipment that requires calibration, validation, and/or preventative maintenance have defined processes for documenting that these steps have occurred and are available for monitoring review during the study. The timing and logistics of sample testing should be explained in the protocol and during study training, and operators must understand how to perform testing with the investigational device(s) as well as operate any equipment required for sample processing. Reasonable safety precautions when working with any biological material is always advisable, but for samples that are known to be or may be biohazardous, such as those used for infectious disease studies, proper biohazard precautions must be in place and the biohazard training for study personnel handling these materials documented.

Your protocol should define disposition of samples following processing or testing. If samples are to be discarded, their disposal must be documented. If sample retains are kept, their storage parameters should be made explicit in the protocol and storage conditions documented throughout the study. If samples are to be returned to a central laboratory or Sponsor for storage, shipping conditions should be outlined in the protocol and evidence kept as part of study documentation.

Optimizing Sample Storage and Shipping

As the sample is key to obtaining data in IVD studies, storage conditions that maintain analyte stability within the sample type and a well-documented chain of custody are paramount. At the outset of study planning, defined acceptance criteria should be established for factors affecting analyte stability such as sample collection and storage temperature, number of freeze/thaws, and time elapsed from sample collection to processing, testing and/or storage. Storage and shipping conditions during the conduct of the study need to align with the parameters contained in the protocol, and these conditions must be documented through various types of records including temperature logs, transit receipts, or records of the date and length of time each sample is removed from storage (for testing or shipping). Study sites should be able to always show the location and storage condition of all samples.

All sample handling must also be documented, as well as the condition of samples prior to shipping and upon receipt. In addition, it is important that any personnel responsible for sample collection, processing, handling, storage, or shipment be trained on the study and have a record of their qualifications, training, and responsibilities included in study documentation.

Managing the logistics of sample storage and shipping can be a challenge. Sites must ensure that there is an availability of storage space meeting protocol storage temperature and security requirements for the duration of the study. Any storage equipment (e.g., freezers or refrigerators) should be validated and have traceable, controllable temperature monitoring and a back-up system in the event of failure. Knowledge of shipping logistics and processes is essential, especially if the study requires same-day sample processing outside of the sample collection site. Local conditions may need to be taken into consideration during particularly cold or hot weather, as this may impact sample storage conditions during transit.

Partnering to Protect Your Sample Integrity

A comprehensive sample management plan involves meticulous oversight of the sample journey and documentation demonstrating that samples are handled in a manner that preserves their viability and adheres to the protocol. When samples are collected, processed, stored, or shipped incorrectly there is the greater potential for false or invalid results, damaging the integrity of the study. By considering sample management from the beginning of study design, the most effective and efficient sample handling procedures can be built into the protocol.

Leveraging Beaufort’s diagnostic expertise and team of experienced IVD clinical research professionals and established investigational sites, can ensure that your study’s sample management is streamlined, well-executed, and meet all regulatory requirements and all samples maintain their integrity throughout the entire sample management process.

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DEFINING THE INTENDED USER AND USE SETTING

The performance of IVD products depends not only on the accuracy of a test, but also on the user performing the test and the testing environment. Because of this, defining the intended user and intended use setting of an IVD is one of the most important considerations for development, figuring into risk-based classification, test complexity, appropriate regulatory submission(s), and study design requirements.

In general, more stringent regulatory requirements are associated with tests that have a higher likelihood of error by the intended user.

In general, more stringent regulatory requirements are associated with tests that have a higher likelihood of error by the intended user. In cases where user error is more likely, a waived IVD may receive a higher risk classification (Class II vs. Class I), and require more regulatory oversight (e.g., a Clinical Laboratory Improvements Amendments of 1988 (CLIA) waiver application that includes additional studies) to ensure that users can reliably conduct the test and interpret it correctly.

The likelihood of error by the user is influenced by:

The degree of specialized knowledge required to perform the test
The degree of user training and experience for preanalytical, analytical and postanalytical phases of the testing process
The degree of judgment required to perform the test and interpret the results
Whether operational steps are manual or automated
Whether quality control and calibration are available
Whether reagents and materials are stable or require special handling
Whether troubleshooting requires decision-making or is automatic

Effect of user and use environment on regulatory pathways:

A test that is intended to be used near patients (a point-of-care [POC] test) may be considered higher risk and require a more stringent regulatory pathway than one that is conducted in a laboratory setting. Consider the case of a cholesterol test, used in the diagnosis and treatment of disorders involving excess cholesterol in the blood. In the U.S., when conducted in a central laboratory, the test is classified as lowest risk, Class I, and is exempt from premarket notification procedures such as 510(k). However, the exemption from premarket notification no longer applies if the same test is intended for near patient (POC) testing.

Effect on regulatory requirements:

The user and use environment may also impact the “complexity” of the test, which, in turn, affects regulatory requirements. Specifically, in the U.S., an IVD’s test complexity will inform whether laboratory certification by CLIA is needed, or whether manufacturers will need to submit a CLIA waiver application. All U.S. facilities that perform laboratory testing on human samples for medical reasons are regulated under CLIA, which established quality standards for laboratory testing to ensure the accuracy and reliability of results in the intended use setting.

The FDA categorizes clinical laboratory tests by their complexity — from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. The FDA determines test complexity by reviewing the package insert test instructions in the premarket submission using the criteria listed in 42 CFR 493.17. The tests that are not waived by regulation under 42 CFR 493.15 and are not cleared or approved for home use or for over-the-counter use may be categorized either as moderate or high complexity.

In addition to submitting premarket notification, manufacturers whose tests are intended to be used for near-patient testing (POC), must also submit a CLIA Waiver by Application, which can be submitted separately from the 510(k) submission or through a dual 510(k) and CLIA Waiver by Application (Dual Submission) 510(k).

In general, a CLIA waiver requires the following additional studies:

“Flex studies” demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress
A user study demonstrating that the test is simple to perform and has an insignificant risk of erroneous results in the hands of untrained operators in CLIA-waived settings

Effect on clinical research study design:

In studies, IVD testing must be conducted by the intended users of the product. Study site and personnel considerations need to be planned for IVDs that require more technical skill sets and specific equipment to ensure that these resources are available and that the location is appropriately qualified to conduct laboratory testing. Likewise, a testing-naïve population would be required in the design of studies in which patients collect the samples or conduct the tests themselves, as in the case of IVDs designed for home use.

Additional IVD study considerations — such as the need for informed consent or a Waiver of Informed Consent in the U.S. or General Data Protection Regulation (GDPR) disclosure in the EU – will depend on the type and nature of the patient information to be collected during the clinical study and the type of study procedures to be performed, including study-specific sample collection, and any risks to the patient.

DEFINING THE INTENDED USE (OR INTENDED PURPOSE) AND INDICATIONS FOR USE

The IVD intended use encompasses the intended user, intended use setting, the indication for which the test will be used (e.g., oncology, sickle cell disease, infectious disease), and what the test results will be used for, such as prognosis, diagnosis, screening, monitoring, or management or prediction of treatment. Some IVDs are also intended to provide information, which guides the use of a corresponding therapy.

A properly defined intended use is critical to identifying the appropriate risk classification of an IVD, the regulatory pathway and associated study design considerations.

A properly defined intended use is critical to identifying the appropriate risk classification of an IVD, the regulatory pathway and associated study design considerations. As part of a quality management system, a sponsor should assess the risk associated with the design, manufacture, and intended use of the IVD. Based on this assessment, relevant standards, references, and regulatory requirements can be identified and studies can be designed as a means to mitigate those risks.

Of note, companion diagnostics (CDx), which are used, for example, to identify patients who are most likely to benefit from a particular therapeutic product, may have rigorous regulatory requirements and considerations that are distinct from other types of IVDs. Because companion diagnostics provide information that is essential for the safe and effective use of a corresponding drug or biological product, companion diagnostics are often classified as Class III devices in the U.S., requiring premarket approval.

PARTNER WITH EXPERIENCE, PREPARE WITH CONFIDENCE

Sponsors face many decisions when planning to place their IVD on one or more markets. There are a wide range of interconnected considerations that can impact both timelines and budget. Ensuring that the product development and study designs are aligned with the regulatory strategy and requirements is critical.

Companies planning to commercialize an IVD should consider all applicable regulatory requirements as early as possible in the development process. In our experience, sponsors benefit from working with a full-service CRO partner with IVD services experience to ensure (1) a thorough understanding of all the regulatory requirements; (2) the proper design for the appropriate number and type of studies; and (3) the effective implementation of study protocols.