Slope Blog

Requisition forms have long been considered essential for transmitting vital sample metadata between research sites, labs, and eventually sponsors. Without this data, labs can’t report results, sponsors can’t defend the integrity of their samples, and studies can’t proceed with critical milestones like interim analyses and database locks.

Slope recently welcomed Amanda Schreiber as the newest addition to our Biospecimen Data and Operations team. Amanda brings a wealth of experience to the team, having worked in various capacities with sponsors, research sites, labs, CROs, and other vendors over the course of her expansive career.

Imagine you’re a brilliant interior designer with a vision for transforming a space into a masterpiece. You know exactly how you want the room to look, but bringing that vision to life requires more than just your expertise. You need skilled contractors, electricians, and plumbers to ensure your design is executed flawlessly. 

Imagine you’re managing a rare disease trial where every single patient sample counts. In this study, samples are first shipped to a central lab before being sent to a specialty lab for crucial testing.

As a sponsor running a clinical trial, your success hinges on your primary and secondary endpoints — including safety, biomarker, and PK samples that must be collected and analyzed at precise intervals. 

If there’s one thing we can all agree on when it comes to running a clinical trial, it’s that time is of the essence — especially when delays impact patient outcomes. 

In clinical trials, database locks are critical milestones that must occur during the transition from data collection to data analysis and regulatory submission. This process ensures that the data pertaining to each biospecimen is clean and complete before it is used in any official capacity.

If you’ve watched any of the track and field events at the Olympics, you’ve likely been blown away by the lightning-fast reflexes of an Olympic sprinter. In order to be among the fastest runners in the world, these athletes must follow an extremely regimented training program to ensure they are physically and mentally prepared for the biggest day in their athletic careers

Imagine you’re leading a translational medicine team at a sponsor organization, and you're faced with the critical task of assessing your protocol endpoints for an ongoing study. The stakes are high, and your decisions will shape the trajectory of your organization’s research. 

When it comes to running a clinical trial, tracking sample shipments from research sites to various labs is a critical part of monitoring the biospecimen lifecycle; but as many of us know, executing on this is far easier said than done.

It’s no secret that without labs we wouldn’t have clinical trials. Labs perform the assays that generate the safety and efficacy data needed to support primary and secondary endpoints in the study protocol. Without labs, the data required to bring new drugs to market would simply not exist.

Picture this: You're the Director of Clinical Operations for a sponsor organization, and it's 9am on a Monday. Your phone rings — it's someone from leadership asking for an urgent update. "Are we on track for the next dose escalation?" they inquire. 

Sample metadata is critical to executing a clinical trial. Every bit of information about biospecimens — including sample and visit identifiers, collection dates and times, patient demographics, and pre-analytical variables — not only demonstrates the integrity of patient samples, but also gives sponsors valuable insight into site performance, study milestones, and more.

Imagine you are responsible for overseeing the management of all biospecimens collected across multiple clinical trials. Today, you received an urgent request from one of your colleagues: they need the current status of a specific tissue sample collected three weeks ago on a global trial because the sample is overdue for analysis.

Accurately capturing and communicating sample metadata across various sites and labs can significantly impact the success and efficiency of a study — influencing everything from decision-making to the ability to report lab results. 

Imagine you’re navigating the icy waters of the Arctic. You spot an iceberg and steer clear, aware that what you see above water is just a small fraction of its total size. The real risk lies beneath the surface, where the majority of the iceberg remains hidden from view. 

Prior to 2018, Gabrail Cancer Center was drowning in lab kits. As the Ohio-based research site’s oncology trial pipeline continued to grow in tandem with a rise in study complexity and patient enrollment, the amount of inventory that it had to manage grew exponentially.

In the high-stakes world of clinical trials, the success of translational medicine hinges on the integrity of sample data. Those who support translational medicine on behalf of sponsor organizations are acutely aware that the validity of their scientific hypotheses is only as robust as the quality of their patient samples and the data associated with those samples.

During my 25 years working in clinical trial operations, I’ve seen the biopharmaceutical world talk a big game about making the process easier for the sites running the trials and the patients participating in them. Everyone from trial sponsors to the Food and Drug Administration has been quick to promise simpler processes, less hassle, and better experiences for everyone involved.

Whether you enjoy cooking or not, we can all agree that you can’t make a recipe without an ingredients list. This list is crucial, because it outlines exactly what you need to create a dish, including the specific items and their quantities.

Clinical trial sponsors come in all shapes and sizes. But one clinical trial sponsor that doesn’t get enough love is the research site. Yes, we’re talking about investigator-initiated trials (IITs). IITs share certain things in common with industry-sponsored trials, but they also come with their own unique challenges that demand a solution.

Buildings are one of the great marvels of human ingenuity. Every man-made structure, from the pyramids of Ancient Egypt to the skyscrapers of today, were the direct result of intricate planning and careful execution. 

At Slope, one of our five core values is, “Patients are paramount.”If you work in clinical research in any capacity, this sentiment likely resonates with you too. Every single one of us, in some capacity, has been or will be touched by the devastation of disease.

If you work at a research site, chances are you’re extremely familiar with the EDC. In most cases, sponsors rely on the EDC to access site-generated data pertaining to any samples that are collected for their trial. 

The Ancient Greek philosopher Aristotle once wrote, “Well begun is half done.” This statement emphasizes the importance of a strong start, suggesting that laying a solid foundation at the outset of a project or goal can greatly contribute to its overall success.

It goes without saying that clinical trial integrity and study outcomes hinge entirely on data. Sponsors and regulatory authorities use lab data to determine the safety and efficacy of a drug, but they also require even more data (also called biospecimen data or sample metadata) to confirm the integrity of the samples that were tested to yield the safety and efficacy data. 

Clinical trials take place across a complex network of systems and vendors who manage patient samples and sample metadata. Each time biospecimens change hands, the associated metadata that identifies what the samples are, who they belong to, their chain of custody, and other data points that are relevant to sample processing — must travel with them. 

If you’ve ever worked at a clinical research site, then you’re familiar with the protocol-specific training that occurs when your site is initiated for a new study or when a new protocol amendment is rolled out. Given that almost every trial today has its own unique set of processes, coupled with a complex study design, this training has become increasingly critical for site staff. 

Over the last several years, there has been a lot of talk in clinical research about digitizing requisition forms — the paper-based documents that sites use to record patient-, visit-, and sample-specific metadata that is then entered into lab information management systems (LIMS). Requisition forms play a critical role in the flow of information from sites to labs, as the data that site staff document on the requisition is then used to demonstrate several key variables, including patient eligibility for a trial (based on factors like birth year and patient sex); sample stability (based on collection date and time), sample processing history (for important samples like patient tissue), and more.

Every study coordinator within a given site may have a different way of performing common study tasks, especially when it comes to responsibilities like inventory management. Even tasks that are already more standardized at a research site — like sample management — may involve site staff working with different kitting vendors and different lab manual formats as they navigate specific study requirements.

In clinical research, it’s often said that the one thing that all research sites have in common is that they are all different. Even though the majority of sites who are supporting the same trial are working off the same protocol, using the same lab kits, following the same lab manuals, capturing the same data, and collecting the same samples, each site may have its own unique processes for performing these tasks.

If you’ve worked at a research site, you know that study amendments and modifications are pretty much inevitable. Clinical trials have a lot of moving parts, and as such they are subject to changes both big and small — especially once the study is already underway. 

Sponsors understand the importance of helping their sites stay compliant with protocol amendments and other study modifications that may impact lab kits and lab manuals. These changes can be a lot for sites to juggle — not only because they are managing several tasks across several trials and sponsors simultaneously, but because lab kits and lab manuals that were created prior to the modification may still be in circulation.

As we highlighted in our blog, “How Do Protocol Amendments Factor into Your Clinical Trial Monitoring Plan?,” clinical trial stakeholders should prioritize compliance with the most current versions of study documents, including protocol amendments and lab manual modifications.

Given the complexity of today’s clinical trials, protocol amendments and modifications that impact the lab manual are all but certain. Study changes can happen for any number of reasons, but these updates are likely to have downstream impacts on inventory management and sample management workflows. 

If you’ve ever worked on a trial involving tissue samples, you know that these precious biospecimens are unmatched in their level of importance to clinical research, as well as in the level of complexity required to manage them.

The majority of study coordinators, phlebotomists, nurses, and clinicians who work at clinical research sites chose their profession because of their passion for supporting patients. Clinical trials are particularly exciting because they offer patients access to promising treatments that have the potential to save their lives or dramatically improve their quality of life. But let’s take a moment to consider one of the most important forces behind a clinical trial — patient samples.

In summer 2023, Slope attended the Association for American Cancer Institutes (AACI) Clinical Research Innovation conference, where we co-presented a research poster with the University of Pittsburgh Medical Center Hillman Cancer Center (UPMC Hillman).

Clinical operations professionals are always looking for ways to finetune their monitoring strategies. As we evaluate the entire clinical trial lifecycle for gaps and opportunities for optimization, we tend to look at the workflows that have the greatest impact on study outcomes — the processes that directly influence the integrity of study data.

Efficient and effective lab kit management is vital to the success of a research site’s clinical trial operation. As we highlighted in this blog about the synergy between sample management and inventory management, patient samples are more prone to mishandling when sites don’t have a well-organized and efficient lab kit management system in place.

When it comes to clinical trials, lab kit waste is a hot topic. Not only do expired collection supplies wreak havoc on study budgets, but their impact on the environment and on relationships with research sites is undeniable.

As we uncovered in our blog, “Oh No! My Research Site Experienced a Protocol Deviation, and It Was Our Mistake! What Now?”, sites can minimize preventable protocol deviations by implementing certain best practices. But in order to understand why these strategies are effective, it’s important to dig into the factors that cause avoidable violations in the first place.

It’s no exaggeration to say that precision medicine is the future of drug development, particularly for rare diseases and cancer. When a drug targets a specific biomarker to fight disease at its source, it provides a complex but powerful goal: targeting a precise mechanism of action in a subpopulation of individuals with a disease.

n the fast-paced world of clinical trials, the smallest oversights can have significant consequences. Let’s imagine that your research site is screening a cancer patient for a promising oncology trial. Amidst the rush of conducting the patient visit and managing the patient’s samples, multiple missteps occur.

Protocol deviations are an all too familiar challenge during clinical trials. Yet despite their frequency, it’s vital to recognize the significant impact that deviations can have on both data integrity and patient well-being.

If you work at a research site, chances are you have had to work in some capacity with site monitors — also known as clinical research associates (CRAs). Oftentimes, site monitors are contracted by the sponsor through a CRO, and their primary function is to support clinical trial monitoring activities as dictated by regulatory guidelines and sponsor-specific needs.

In an ecosystem that’s inundated with clinical trial tech, complex processes, and disconnected stakeholders, sponsors have their work cut out for them when it comes to selecting clinical trial vendors and systems.

We all know that it takes a village to run a clinical trial. But how does this impact research sites, who are on the front lines conducting patient visits, managing patient samples, and collecting important biospecimen data?

It’s no secret that sponsors maintain oversight of monitoring strategies and monitoring plans for their clinical trials, but it’s research sites that are at the heart of most clinical trial monitoring activity. As the study stakeholders who are on the front lines managing patient samples and collecting source data, research sites are subject to significant scrutiny in their efforts to execute the work of clinical trials cleanly and succinctly. 

Clinical trial monitoring plans are essential to ensuring the completeness and accuracy of reported study data based on currently approved study documents and regulatory requirements.

As stewards of clinical research, sites need to execute on protocol designs and study plans for every trial that they support with significant precision. As a result of the complex science that today’s innovative treatments and therapies demand, coupled with the need for the involvement of several vendors on every trial, executing on lab manual procedures can be a daunting task. 

When it comes to clinical operations, one of the core functions of monitoring is to prevent research site compliance issues and quickly identify them when they do occur. ClinOps leaders bear primary responsibility for spearheading the monitoring plan for a trial, implementing new monitoring approaches, and more.

With the 15th annual SCOPE summit in Orlando, Florida, just a few weeks away, Slope is excited to announce our in-depth presentation on “Bridging the Biospecimen Data Gap.”

Lab manuals are an integral resource in the vast majority of clinical trials. In coordination with CROs and various lab vendors, sponsors will compile lab kit management and sample management procedures for their trial into one concise document that offers guidance to their research sites.

As we emerge from the holiday season refreshed and ready to hit the ground running in 2024, we’re also reflecting on our commitment to building community within our industry. 

Most research sites intimately understand the challenges with implementing study amendments on clinical trials. Complex trials are more likely to undergo changes that may impact the Schedule of Events, lab kit contents, lab manual instructions, and more.

This week, Slope announced the appointment of its new Chief Operating Officer, Terry Edwards. As the founder and former CEO of PerfectServe, a digital healthcare company that specializes in clinical communications and collaboration, Edwards successfully oversaw the company’s scale-up over the course of over 20 years before a private equity exit in 2018. 

Last week, representatives from several sponsor organizations joined Slope in Boston for an advisory meeting to discuss trends in biospecimen management and operations. Slope led a discussion on these trends which spoke to some of the prevalent issues that are complicating sample management and data management across the clinical research landscape. 

It’s no secret that lab queries present a major obstacle for research sites in their clinical trial operations. Study coordinators and dedicated site personnel often balance multiple trials simultaneously — managing patient care, clinical inventory, and patient samples through a disjointed web of manual, disconnected, and sometimes paper-based processes.

In the world of clinical research, study coordinators often grapple with the challenging task of managing lab kits and clinical inventory by cobbling together paper trails, sticky notes, and spreadsheets.

Earlier this month, representatives from research sites, sponsor organizations, CROs, and regulatory agencies gathered in Hollywood, Florida, for the 2023 Global Site Solutions Summit. Attendees came together to discuss best practices for research sites through ideation sessions, workshops, and focus groups.

Smooth, end-to-end biospecimen management is one of the keystones to enabling the development of life-saving patient therapies. Not only are more clinical trials in flight than ever before, but studies are also getting more complex.

Slope is proud to be Certified by Great Place To Work® for the first time! The prestigious award is based entirely on what current employees say about their experience working at Slope.

This past week, over 800 attendees representing various clinical trial sponsor organizations, vendors, and patient advocacy groups converged on Boston for the 13th annual DPHARM conference to examine how the industry can leverage innovative approaches to solve today’s problems in clinical research.

Picture this: you’re a study coordinator at a clinical research site, and your organization has recruited a sick patient to screen on a trial for an exciting new study drug.

On September 12th, CancerX — a public-private partnership aimed at boosting innovation in the fight against cancer — introduced its inaugural steering committee and strategic priorities for the coming year.

Insights from Sample and Data Reconciliation Roundtable: Current Practices, Modernizing Strategies and Supporting Sites, How to Achieve Optimization

In the world of clinical trials, meticulous planning is critical to optimizing the success and reliability of study outcomes. One of the key decisions that trial sponsors must make is when to have clinical research sites send samples to a central lab versus when to have them ship samples directly to specialty labs.

Clinical research sites are on the front lines of study execution; in order to ensure their success, it’s important to understand their current challenges with sample management, as well as their strategies for circumventing those obstacles.On August 9th, Slope hosted a virtual roundtable discussion where attendees talked through methods for handling sample management in their trials with other industry professionals.

In the ever-evolving landscape of clinical trials, sample management and inventory management are inextricably intertwined.

During our roundtable last week on Working Effectively with Biospecimen Labs, Slope facilitated a discussion on key challenges ranging from queries, lab to lab transfers and sample reconciliation, to site training and amendments.

Site staff find themselves having to keep track of collected and processed patient samples in paper sample logs or in self-created spreadsheets — but why?

Lack of comprehensive knowledge about sample status, including collection, processing, location, storage, shipping timelines, arrival at the lab, and testing schedules, can impede the availability of vital data required for dose escalation. In this blog, we outline the top 5 mistakes frequently made by early-phase clinical operations professionals that hinder dose escalation.

At the Association for American Cancer Institutes (AACI) Clinical Research Innovation conference in Chicago, IL, we debuted a research poster created in conjunction with the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center.

#DIA2023 is well underway. One of the more interesting and timely sessions was surrounding accelerated approval in rare disease, highlighting the role of novel biomarkers, surrogate endpoints, and other innovative approaches in expediting development.

In today's fast-paced world, technology has become an integral part of the clinical research landscape. However, the traditional approach of focusing on "sponsor tech" or "site solutions" falls short of harnessing the full potential of technology.

We recently introduced our new team member Carlos Pigotti as we were approaching Clinical Trials Day. To keep the celebration of research going, we are excited to share a little more about Carlos’ experience, his passion for clinical research and process optimization, and his views for the future.

We all recognize that proper sample management is essential. As a sponsor, it is essential to ask the right questions about sample management to mitigate those risks. 

Launching a clinical trial is a complex endeavor that begins with numerous hurdles. Study startup brings with it a range of challenges, including contracting and budgeting issues, site selection difficulties, as well as regulatory and financial barriers.

Clinical trials, known for their inherent chaos, have experienced a significant surge in numbers over the past two decades. From a mere 1,000 studies registered in 2000, we now find ourselves grappling with a staggering 400K+ trials as of 2020 — and that number is only increasing.

As we look forward to celebrating Clinical Trials Day this upcoming Saturday, we took a moment to ask a few of our Slope employees that have prior clinical research experience to reflect on what brought them to the field of clinical research, what inspires them, and their hopes for the future of clinical trials.

Ensuring the data integrity for all the samples — traveling from sites to central labs, to specialty labs, to biobanks — is traditionally a fragmented, labor-intensive, and siloed process.

We are excited to introduce our newest team member, Gabrielle Jones, who recently joined Slope as a Site Development Consultant. To help you get to know Gabrielle a little better, we conducted a Q&A interview with her at this weekend’s ACRP conference.

As a clinical research coordinator, one of the most surprising experiences when starting the job is being overwhelmed with supplies.

Billy was diagnosed with Duchenne Muscular Dystrophy (DMD) at the tender age of four. At 10, he enrolled in the first-ever U.S. exon-skipping clinical trial and has been on infusion-based therapy ever since. Now a young adult of 22, Billy reflects on his experience as a clinical trial patient and the valuable lessons he learned throughout his journey.

As a parent, you would do anything for your child, especially when it comes to their health. You do your best to stay positive, discover an inner strength and energy that you didn’t know you possessed, and become their strongest advocate.

Clinical trials require devices, lab kits, and associated supplies, diagnostic equipment, shippers, freezers, centrifuges, and investigational product (IP).

Slope recently presented at #FOB2023 on the topic of value-based study planning as a way to improve site and sponsor experiences.

In our latest blog, we touched on how Slope's founders leveraged their e-commerce supply chain expertise to solve supply chain issues in clinical trials.

The phrase "we've always done it this way" often elicits a strong emotional response from many of us in the pharmaceutical industry.

Edye Edens is a licensed attorney with an international human rights, ethics, and health law background, who was in-house counsel for a decade with a major academic medical center.

Sample management is a term that can have varying definitions depending on who you're talking to and their involvement in the sample journey.

We think they are. Clinical researchers are some of the most dedicated, passionate, and driven individuals, developing new therapies to combat devastating diseases and improve the world. They operate at the forefront of scientific advancement, and their work is truly remarkable.

Slope today announced the closing of a $20 million Series A financing, led by global venture capital firm New Enterprise Associates, Inc. (NEA), to accelerate go-to-market efforts and further expand into decentralized and direct-to-patient clinical trials.