Optimizing Current and Future Biotech Research Results
4 ways clinical operations professionals can optimize clinical study outcomes
The quality of a biospecimen can influence the outcome of pharmaceutical and biologic studies long before the actual research begins: Non-standardized collection materials, improper processing procedures, and inadequate storage conditions enter the biospecimen life cycle in the form of pre-analytical variability, ultimately impacting the outcome of your study.
Downstream stakeholders, most often researchers and data analysts, have limited visibility of the biospecimen life cycle. They assume proper material, technique and protocol adherence has been accounted for. Typically this doesn’t become obvious until late in the study, when timelines and budgets are under increased scrutiny and redoing a study isn’t an option.
Sponsors have begun to take notice of this common oversight, and are leaning on the expertise of clinical operations specialists to standardize and integrate study logistics and biospecimen availability and quality. Clinical Ops teams are challenged to deliver upon more precise protocols & studies, within tighter budgets, and an increasingly competitive clinical environment.
Setting your organization and study apart from other Sponsors, through the use of site-friendly clinical materials and procedures, will ensure delivery on the challenges of today and build a foundation for future studies.
Following are 4 best practices to weave the likelihood of success into your clinical program from kit to collection:
1) Understanding the Process Flow at Investigator Sites
Lagging enrollment isn’t always the result of low patient targets. In many programs, it’s the undesirable outcome of study designs that didn’t take the flow of routine patient care at the site into consideration. Each practice (investigative site) is unique, and so are the roles and personalities within them.
Get to know the flow — beginning with a site interview — to find path of successful enrollment/specimen collection. Use the following key points to frame your discussion:
- Consent: Who will obtain it and where?
- Collection: Where will it be collected? (in the exam room, draw station, elsewhere?)
- Processing: Does the specimen need to be transported elsewhere for processing? (on-site lab, outsourced?)
- Short term – Long term Storage: Where will the biospecimen be held, and how will it be stored until it is shipped to the laboratory?
Involving each site’s key role players in this process — the nurses, administrative, and laboratory staff — ensures that the “intangible” influencers of your enrollment success are accounted for in the study design.
Understanding the flow of patient care in the clinical setting (including staff roles and available resources), and building this into the design of study procedures and supplies will increase the likelihood that your study is the one to which coordinators prioritize.
2) Utilize Site-Specific Study Kits for More Flexible Collection
In today’s clinical setting, there are a number of role players responsible for providing efficient, quality patient care — making it unlikely that any single person will perform every step in the process of your study, from enrollment and data capture to specimen collection and management.
For this reason, it is poor practice to create one-size-fits-all study kits that travel with the patient throughout their visit. Managing the enrollment and collection process in this way introduces unnecessary risks that can potentially impact the quality of biospecimens.
A better way to manage the process is to create site-specific study kits that balance the process of care with specific study procedures to ensure efficient and accurate compliance with the study protocol.
For example, many sites perform phlebotomy in the clinic, while centrifugation, processing, and aliquoting occurs in a separate suite or building. For these sites, the optimal study design would incorporate two process-specific study kits linked together with a common identifier.
An example of this type of solution is;
- Collection Kit; for consent, enrollment, and collection
- Processing Kit; for separating, aliquoting, and storing the specimens
Utilizing site-specific study kits that align with patient care and staff workflow enables efficient utilization of resources and precise handling of biospecimens.
3) Standardize Study Supplies
Slight variations in materials and supplies can affect the recovery and performance of samples in subsequent clinical or molecular analysis. Unfortunately, the person who is impacted the most by this — the researcher — is typically not involved in selecting the collection or processing materials.
Involving the end user in the qualification, selection, and standardization of supplies can help Clinical Operations professionals avoid downstream performance and research variability.
A collection tube is a great example of how a simple component can result in unexpected research results. Here is a real-world example:
A study was designed to correlate unique biomarker levels in plasma to a known disease state. The project manager for the research team contacted clinical supply to order collection kits containing plasma tubes with K3 EDTA anticoagulant.
The collection was complete after 12 weeks, and the specimens were sent to the CRO, who performed the analysis and returned the testing to the researcher at the Sponsor. The researcher was concerned by the results, because they did not correlate to the disease state in the same manner as research he had conducted in his own lab. An investigation ensued, and everything from patient specific treatments to lab testing methodology to ischemic times during processing were considered. Still, there was no tangible explanation.
The researcher requested an additional 10 patients be collected as a last resort. While organizing the materials, the project manager was informed that the K3 tubes were on backorder. The project manager conveyed this information to the researcher, and inquired whether there was a different tube she would like to use. The researcher’s response solved the mystery: K3 EDTA tubes should not have been used in the collection of the specimens. Previous studies had ruled out this collection tube, due to inconsistent activity of this biomarker. A K2 EDTA Plasma tube should have been used in the original study kits.
Had the project manager involved the researcher in the initial design of the study kits, 14 weeks of enrollment and testing, countless hours of investigation, and significant budget dollars would not have been wasted.
Clinical operations professionals that maintain the standardization of study supplies instill confidence in the expected results and reproducibility of current and future research.
4) Develop Clear Instructions and Simplified Labeling
The benefits of flexible study design can quickly be diminished by complex back-end identification and labeling procedures. Manual identifiers (e.g. scribing study visit details on the cryovial labels) add labor, increase the risk of error and extend ischemic time, yet provide no clear benefit. Standardized label formats and integrated identification sequences (i.e. Parent-to-Child ID formats), supported by clear, concise instructions, will ensure the accountability and quality of the biospecimens.
Consider: How much information is too much information?
Study Labels should be formatted to serve the key purpose of accountability and — where automation is planned — barcoded. eCRFs, LIMS, processing logs, and even Excel spreadsheets should be used to capture the secondary and tertiary data. This type of system-wide standardization will help minimize the impact on patient care and office operations.
At ProMedDx, we have more than 20 years of experience with standardizing study procedures for the clinical setting and unique expertise in the design of protocol-specific study kits and logistics.
Contact us to learn more about how we can help you optimize your research operations.
Clinical trial therapeutics and biospecimens are temperature-sensitive, so transporting and storing them locally and/or globally can be complex. Every day, frozen biospecimens are shipped and received, creating new logistics and storage challenges for even the most experienced supply chain and clinical operations managers.
By identifying a trusted Biostorage Service Provider early in the product development life cycle, Clinical Op’s Managers can ensure proper planning, validation, mitigation and reporting.
Whether that provider is an in-house solution, or outsourced partner, there are specific controls and safety measures that require careful consideration in order to mitigate risk of damage or delay.
Here are the top 4 considerations to include in your biostorage partner search:
Biostorage and Biologistics are increasingly important for maintaining product quality and accommodating the moving timelines of stakeholders such as sponsors, investigators, and researchers. Having a solid plan in place will help eliminate potential biostorage issues that could prevent your biopharma from delivering key discoveries and innovations.
A Biostorage or Biologistics plan should address whether you will accommodate biostorage onsite or outsource, the level of security you plan to provide, and how you will scale up if your inventory or demand suddenly increases.
Onsite vs. Outsourced Biostorage
Carefully consider the Capital Requirements for onsite storage, including the cost of freezers, Dewars, specimen management & temperature monitoring, and back-up power systems. Staffing is also important, as you will need skilled personnel with the proper Certifications & Accreditations, capable of operating with precision within temperature controlled environments.. Lastly, you will need to plan for security, back-up security and 24/7/365 monitoring to protect the biospecimens you are storing. If you can’t confidently manage all of these issues in-house, it’s time to consider outsourcing.
If you choose to outsource, look for a Biostorage Service Provider with experience in cold chain logistics, not just storage. Providers should offer proven strategic expertise in planning, packaging, and transporting temperature sensitive materials.
Certification and expertise is a must. Check to see that a potential Biostorage Service Provider has:
- Documented experience
- IATA Certification
- Specialized personnel
- Documented Quality Assurance System that includes SOP’s for hiring, training, and auditing
- Proven adherence to HIPAA, GCP, GMP, GTPGLP
- 21 CFR Part 11 compliant Inventory Management System
- A Secure Access Web Portal
Make it a priority to choose Biostorage facilities & systems designed to support changing needs. You may not currently foresee an expansion, but it is always a possibility, so you should know how you will accommodate a larger inventory.
Undocumented biospecimen storage practices can lead to a lack of confidence in the reliability of generated data. That’s why it is critically important that Biostorage Service Providers use robust, validated processes and controls. Standards to measure by include:
- cGMP compliant facilities
- Controlled access & reporting of assets
- Environmental controls, such as facility temperature & humidity
- 21 CFR Part 11 compliant monitoring
Mitigating risk with documented controls gives you the assurance that your organization’s biologics are secure in the event of an incident at your facility. Whether you are storing biospecimens onsite or off, they should be properly monitored and protected with:
- A 24/7/365 alarm response
- “at- temperature” redundant storage units
- Back-up power
- Regularly scheduled equipment maintenance
- Calibration in compliance with manufacturer’s specifications
- Inventory tracking from receipt to distribution
- Audit-ready processes
Your organization is responsible for upholding all regulatory mandates related to the procurement of human biospecimens, and should be prepared to address reporting requirements and audits. Be sure your chosen Biostorage Service Provider can give you the proper data access and frequency of reporting to successfully monitor:
- Inventory activity
- Access activity
ProMedDx delivers nearly 20 years of biologistics, biostorage, and biospecimen distribution expertise, providing complete control and transparency to biomaterial control and fulfillment. Our team of experts can assist you in your planning with an end-to-end solution and cGMP compliant workflows that protect biomaterials and research participants while providing the documented source to validate clinical trial data. To learn more, contact us or simply call 800.785.7808.
Have you noticed that each year the importance of your research increases, yet available space in your research lab decreases? The culprit, your success! You see, the more research you do, the more biospecimens you gather – the more biomaterials you produce, the more freezers you need to store them. Like an athlete sitting in a room full of trophies/medals, there comes a time to delegate history to a safe place, and create more functional space for your next success. A secure off-site biostorage facility may be that safe space.
Signs that it might be time to consider off-site biostorage:
Rents are increasing, and available Lab Space is decreasing.
In a recent report by the Boston Business Journal, laboratory space, in greater Boston averages $47.40 …in Cambridge it exceeds $51 /sq. ft. At rates this expensive, you need to maximize your investment by making every square foot cost-effective. While very important, the storage of legacy specimens, mirror supplies, and reagents, are likely consuming expensive lab space better suited for current research. An economical off-site storage solution, will open up working lab space providing immediate on-site access to your time sensitive materials.
Are your researchers Researching? … Or managing inventories of specimens?
If you’re working in Finance, chances are your answer is “of course”. If you’re managing a Lab, the likely answer is both. Overcrowding of labs by Freezers – Refrigerators – and Files creates an operational maze…and increases the risk of misplaced or damaged research specimens. In most labs, each lab tech must protect and manage their own research assets…resulting in operations that are both inefficient and unfamiliar to employees who are accustomed to operation according to protocol. Organizing and protecting your research materials today and having them available tomorrow, is one of many the many benefits of an off-site biostorage partner.
Are you being challenged to provide a range of storage conditions?
Today’s precision research calls for precise-stable storage environments. No single chamber can accommodate the range of temperature thresholds your research teams demand. So while you are focused on maximizing the impact of each square foot of laboratory, you now have to account for additional capital expenditures to support your team’s research protocols (and the required monitoring, maintenance, and security procedures…and the very thing you cannot create, SPACE).
The greatest of plans can easily be interrupted and redirected by a simple protocol revision, but it doesn’t have to result in full redesign of your lab. Careful consideration and evaluation of off-site biostorage providers, can result in a real-time, cost effective partner for your short and long term temperature sensitive laboratory materials.
Through outsourcing your storage needs you recapture valuable on-site lab space to expand your research, development and production. Off-site storage provides you unlimited additional storage space, at a wide array of temperature thresholds, quickly, securely, and cost-effectively…enabling your researchers to research.
ProMedDx’s continuously monitored biostorage facility securely manages clinical study samples, research biomaterials, master cell banks, drug compounds, production stock, and other medical products in precisely-controlled temperature chambers. Our proprietary 21CFR part 11 inventory and order management system, enables you to have your specimens in your lab when you need them. Same day or Next day. You can count on the efficiency, security, adaptability, and professionalism of ProMedDx BioStorage.
Contact us today to learn how ProMedDx can help you take back control of your lab.