Whitepapers & Special Reports

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Move from Chaos to Clarity using FAIR Data Principles in Clinical Development

Centralized, real-time, self-service access to clinical trial data and the ability to rapidly apply advanced analytics to get a complete picture of patient safety, treatment efficacy, and trial progress is critical for success in clinical development.

Discover how Signals Clinical™, a SaaS clinical data science platform that provides efficient data handling and processing capabilities, can help your organization streamline clinical data workflows and reduce the time spent on data preparation for analytics, so you can spend more time developing strategic analyses to inform data quality, safety, efficacy and operational decisions.

Whitepapers & Special Reports Archive


The Definitive Guide to Decentralized Trials

Medable’s Definitive Guide to Decentralized Clinical Trials (DCTs) is a comprehensive ebook that demonstrates the transformative potential of DCTs in the realm of drug development. While traditional clinical trial models face various challenges & are taking longer than ever to finish, DCTs offer a paradigm shift by leveraging patient-preferred technologies to enhance participant engagement, improve data quality, & accelerate study timelines by 50%.

This guide covers the core competencies in digital research, such as:

  • Enrollment
  • Screening
  • Consent
  • Data Collection
  • Patient Monitoring
  • Regulatory Considerations
  • Ethical Considerations

You will also learn more about specific DCT methodologies, and their advantages - including increased accessibility for patients in 60+ countries, reduced burden on participants, and enhanced diversity in trial populations.

By providing a complete understanding of this rapidly expanding field, Medable's eBook serves as a valuable resource for researchers, clinicians, regulators, and industry professionals seeking to navigate the exciting future of clinical trials.

The Buyer’s Guide for Search in Pharmaceutical

There’s no avoiding the truth: Getting pharmaceutical drugs to market is a long and expensive process with no guarantee of success. Deloitte estimates that the average cost of the R&D process is currently US 2.2 billion per drug, and it’s only getting more expensive. The drug discovery phase, involving the discovery of novel and innovative compounds, consumes about a third of that investment and takes 10 to 12 years.

Data is the fuel that powers the engine of a well-functioning pharmaceutical company. Data informs research and drives decision-making throughout the drug development process, whether that is during the selection of a target pathway, the confirmation of efficacy and safety through clinical trials, the delivery to market, or its ongoing monitoring.

So how do you drive innovation, accelerate research, and shorten drugs’ time-to-market when the amount of information you have to sift through is growing exponentially?

Advarra Logo
Reporting to the IRB: What Does and Does Not Need to be Reported

It can sometimes be challenging for researchers to remember exactly what to report to the IRB when they are managing multiple reporting requirements for a variety of different entities. The paper also includes a quick reference page to help you easily identify what needs to be reported when.

Data that Informs and Performs: Accelerating Evidence Into Action

In this white paper you’ll gain visibility to the sources, attributes, and capabilities of PINC AI™ Healthcare Data, made up of 20 years’ worth of cost, quality and operational data gleaned from 240 million unique patient encounters from 1100 sites of care. Leading pharmaceutical companies and device industries, governmental agencies, academia, healthcare insurers, and healthcare policy makers use this data for clinical, financial and outcomes analyses.

Perkin Elmer Informatics
The Key to a Faster, More Flexible Clinical Trial Process

Clinical development teams are under enormous pressure to navigate the lengthy and challenging clinical trial process, often needing to alchemize these pressures into opportunities for greater collaboration, risk management, and quality. However, adapting to change while maintaining speed, safety, and data integrity is a challenge that companies of different sizes often experience in unique ways. Learn how clinical development teams can maneuver around potential roadblocks and turn the promise of their investigational product (IP) into a commercial and therapeutic success story.

ArisGlobal Logo
Exploring Enhanced Clinical Collaboration in Modern eTMF Systems

Are you overburdened with TMF documents and data stored in a variety of systems across organizations? Use this eBook to explore the foundation of eTMF systems and how new data standards and technology can ease Clinical team workloads.

Transforming life sciences in the cloud

While the world stopped in 2020, life sciences breathed new life into new, secure ways of working from anywhere.

Download the paper, "Cloud-Based Document Management for Agile GxP Compliance," to see how life sciences organizations boost collaboration and communication for game-changing benefits. Learn how your industry has moved toward modernizing work in light of COVID-19 and see the steps it's taking to make digitization a reality.

The centricity of decentricity: Breaking down the basics of decentralized clinical trials

Patient recruitment, retention, diversity, & safety are all factors driving the need for radical innovation in clinical research. This need was made painfully apparent during the current COVID-19 pandemic.

We can no longer ‘do the same thing and expect a different result’; it’s time to take giant steps forward.

Find out how Medable, the recognized industry leaders in Decentralized Clinical trials, can partner with your organization to digitally transform your clinical protocols. Your research teams can experience benefits such as; improved patient experience, higher quality outcomes data, & savings of US$25,000,000+ for individual studies. Download the White Paper now.

Current Health
Digital Transformation Checklist for Decentralized Clinical Trials

The use of decentralized and virtual clinical trials has accelerated significantly since 2020. These flexible models remove location-dependent barriers to entry and offer access to more diverse patient populations.

But clinical trials that embrace digital transformation have the further opportunity to improve clinical data capture, sustain participant engagement, and support clinical site teams.

Use this checklist as a guide to design your decentralized clinical trials.

Best Practices Guide to Data Privacy in Clinical Trials

As life sciences companies grow, the regulatory compliance requirements and risks expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) into the realm of data privacy.

For high-growth institutions with limited resources & bandwidth, the question arises: what should you do?

In this document, we chronicle some of the regulations affecting the life sciences industry and share 5 activities to help your organization comply with these new and dynamic laws. Though not comprehensive, we hope they provide you with a right-sized approach for your organization.

Slashing Your R&D Cost Can Be Easier Than You Think

This white paper examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. In this quick read, you will learn about the top benefits of a fail fast methodology, how to use technology to improve research results, and you will get simple tips for getting started.

Sanguine Labs
Contributing to Medical Research for a Better Understanding of COVID-19

Recruitment and study challenges existed prior to COVID-19. According to a Tufts Center for the Study of Drug Development report, 48% of study sites miss their enrollment targets, and 11% fail to enroll a single patient.

Copyright Clearance Center
The Evolution and Importance of Biomedical Ontologies for Scientific Literature

The volume of scientific literature being published has increased dramatically in the digital age. Ontologies and taxonomies are important tools to help researchers retrieve and understand this overwhelming amount of scientific literature, but using and managing ontologies can be challenging in itself. In this paper, CCC teams up with SciBite to look at the history of biomedical classification and how these systems have evolved to address new technology and use cases. We’ll explain the difference between taxonomies and ontologies, and discuss the challenges and successes that come with adopting and managing ontologies.

Sanguine Labs
The Continuation of Medical Research while Participant Practice At-Home Isolation and Social Distancing

With most of our daily activities on-hold or modified for the foreseeable future, medical research is a crucial pursuit that continues despite the current environment. Medical research is critical to detecting, diagnosing, reducing, and treating diseases – however, the global pandemic has the potential to disrupt and delay vital research.

Sanguine Labs
Who Owns the Data?

Patient data is increasingly valuable, but there are still questions about who owns that data. Currently, there’s no direct route for patients to share their own information with companies and organizations who want it. New technologies like cryptocurrency and blockchain may be changing that.

Back to Basics: How Foundational Training Can Save the Modern Clinical Trial

Traditional, Virtual, or Hybrid? Trial success really hinges on effective education. Download a copy of our free clinical trial education resource for universal insights into how to optimize everything from site set up to staff training and retraining. Regardless of your chosen disease area and study design, these fundamental pillars are the key to meeting trial timelines, ensuring data quality, and minimizing operating costs.

Cancer Vaccines: Getting Ready for A Decade of Big Breakthroughs and Novel Treatments

Frost and Sullivan recently invited industry leaders in cancer vaccine research to participate in a virtual thought leadership think tank forum. This event bought together leading minds in this emerging field to discuss challenges related to antigen and adjuvant selection, vaccine design, immune response improvement, and future treatment options. Download this white paper to learn more.

Advanced Instruments
Reliable Osmolality Testing of High Concentration mAb Formulations

Osmolality testing has several unique and essential applications throughout bioprocessing, and new use cases are constantly emerging. As the field of biologics manufacturing matures, osmometers and other analytical devices must keep up and even offer new options to remain valuable. The osmolality of monoclonal antibody (mAb) formulations is typically determined using freezing point depression or vapor pressure osmometers. This paper details an evaluation of the OsmoTECH® XT (freezing point) and Vapro® 5600 (vapor pressure) osmometers as a means of measuring concentrated protein formulations.

The Silver Lining of COVID-19 for Clinical Trials

Clinical Trials are a critical component to ensure both safety and efficacy in the development of every new pharmaceutical agent, medical device, or specific protocol. Traditionally, this requires a sponsor to design the trial, for patients to be identified and recruited, and for individual study sites to be located. The study sites are physical locations to which patients must report at appointed times for completing the study protocol. Funding fuels the whole system by covering the costs of supplies, investigator or clinical research organization (CRO) activities, and patient reimbursement. Increasingly, global trends towards digitization have shifted this paradigm of how clinical trials are delivered, elevating the use of decentralized trial technology tools and patient convenience solutions.

Top ten rules for success in decentralized trials

Recently decentralized clinical trials (DCTs) have catapulted to the forefront of clinical research in a matter of months. With approaches like home nursing, telehealth, direct-to-patient (DTP) drug shipments, and mobile sensors, DCTs are making it easier for patients to participate in trials, especially for those who live far away, are too sick to travel, or are too busy. Read Parexel’s latest article by top DCT experts to learn more.

Complion logo
Signed, Sealed, Delivered: Streamlining Regulatory Processes with eSignatures

There are many research documents, forms, and agreements that require signatures. But when time is spent compiling paperwork and chasing down those signatures, Physicians and Coordinators lose precious time. In this article, Jeremy Rigby of Advanced Clinical Research and Neal Surasky of Chesapeake Research Group share their experience for adopting electronic signatures with the Complion eRegulatory software platform.

MilliporeSigma logo
Vetting a Contract Manufacturing Partner for Your Clinical Diagnostics Kit

Do you know your OEM Partner? Choosing the correct contract manufacturing partner for your clinical diagnostics kit is one of the most critical business decisions made during commercialization. The wrong partner could put your business and product at risk.

Isotachophoresis Improves Nucleic Acid Extraction and Purification from FFPE Samples

Researchers and clinicians working with FFPE tissue samples have become accustomed to managing labor-intensive workflows to extract and purify nucleic acids for molecular analyses. Such workflows have the potential to further damage nucleic acids during extraction and introduce bias to downstream analyses. As this white paper discusses, the application of isotachophoresis to purify nucleic acids without using an intermediary binding surface yields higher quality nucleic acid and several benefits to downstream analyses. The white paper reviews a series of experiments conducted with the Purigen Biosystems Ionic™ Purification System to demonstrate an automated application of isotachophoresis and the resulting improvements to workflow, nucleic acid yield, and nucleic acid quality by comparison to conventional methods with data from qPCR-based assays and next-generation sequencing.

Competency-based Training: Why Does It Matter?

While the concept of competency development has been around for quite some time (R.H. White, 1959), it has increasingly come into focus in clinical research as clinical trials continue to become more complex. Competencies can be defined as a set of related skills, knowledge and abilities that enable individuals to act in accordance with the prescribed performance requirements for their roles. Ultimately, these skills enable us to respond effectively to different situational inputs and issues encountered in our jobs. By focusing on employee competencies, organizations can better align business goals and objectives and ensure that the appropriate employees are recruited and selected. Effectively, focus on competencies (vs. only experience) provides employers with the opportunity to distinguish potential for superior job performance vs. average or below average results, and ultimately to better define and control performance in clinical research organizations.

Quest Diagnostics logo
Patient-centered clinical trials recruitment

For more than 50 years, Quest Diagnostics has been providing insights that lead to more informed healthcare decisions. We help deliver better healthcare today and inspire the innovations of tomorrow. Quest Clinical Trials Connect helps drive more cost-effective and timely clinical trials. By connecting the right patients with the right clinical trials at the right time and place, we can help move new medicines from vision to reality and bring new hope to patients and their caregivers.

Quest Diagnostics logo
Improving clinical trial enrollment to help accelerate the time to market for new therapeutics

By leveraging Quest’s relationship with half the country’s physicians and hospitals, a leading pharmaceutical company was able to identify over 1,000 additional physicians to approach for clinical trial participation or physician referral to study sites. This could allow for a higher rate of patient enrollment and improved cost-effectiveness— streamlining clinical trial operations to help bring new medicines to market in a timely fashion.

Patient Centricity and Virtualizing Technologies in a COVID-19 World: Measuring how the pandemic is driving adoption of digital tools in fully virtual, hybrid, and traditional clinical trials.

As the COVID-19 pandemic rages on, clinical trial conduct is being reimagined in ways few thought possible. As all stakeholders rethink how to develop protocols, consent patients, ensure compliance, and gather quality clinical trial data when patients and staff are remote, patient centricity has stepped to the forefront. To quantify this trend, the Society for Clinical Research Sites (SCRS) collaborated with Medidata (a Dassault Systemes Company) to survey and measure current and anticipated levels of adoption of patient-centric tools, and the sites’ perspective on how patients have reacted to them. Counter to expectation, the survey revealed that sites are receptive to virtualizing technologies that facilitate their work while enhancing the patient experience. Inform your technology strategy based on the latest insight.

Addressing Compliance Gaps with Focused Training Programs

Rather consistently over the years, several general areas have comprised the most usual areas of clinical investigator noncompliance, although there are emerging signs that CDER is finding more cases of significant noncompliance today. It can be argued that these areas of noncompliance can be easily addressed with focused training programs. When the root cause of learning need is clearly identified, a well-designed training solution with relevant case scenarios, practice in building new skills, and measurement of learning outcomes can be quite powerful.

Inspection Readiness Begins with the Trial Master File (TMF)

The (TMF) is held by the sponsor and represents the story of the study of the study. The Investigator Site File (ISF) is held by the site and represents the story of the study at the site. These documents are the cornerstone of inspection readiness, and it is essential that both the sponsor and site organizations employ strategies for insuring that their TMF/ISF are prepared for a potential health authority inspection from the beginning of every study. This becomes even more critical as many European agencies conduct routine inspections during an active study. Organizations can not only ensure that the documentation is available and complete, but the documentation must tell the story of a study that was conducted to the protocol using principles of Good Clinical Practice (GCP). Ensuring that your ISF and TMF are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day.

Train, Analyze, Intervene: How a Three-Pronged Approach Improves Data Quality in Dermatology Trials

This whitepaper provides readers with tips on using a combination of rater-training, data analytics, and intervention to ensure the best possible data for dermatology clinical trials.

Overcoming Barriers to Translational and Clinical Research

The use of artificial intelligence (AI) technologies is poised to have a major strategic impact on focus and differentiation, which will redefine the clinical data review and cleansing process. This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

The Importance of Project Financial Management for BioTech

For the Biotechnology industry tracking and managing costs by project has never been more important. This whitepaper addresses the common challenges for companies facing scrutiny from investors and an overall desire to get a better understanding of their business. Discover the improvement that can be achieved with detailed project costing and best practices for project financial management.

Leveraging Technology to Reduce Costs in Clinical Trials

Bringing a novel drug or a medical device to market is becoming more and more expensive, time-consuming and complicated. Yet the urgent need for more cures to both, treat well-known diseases more effectively as well as fight more rare diseases calls for faster and cheaper drug and device development processes, not slower and costlier ones. Likely reasons for the recent rises in drug and device development times and costs seem rooted in the need to safeguard public health through more rigorous regulatory oversight, as well as to protect drug investments through more likely-to-succeed development processes. However, public safety and health as well as drug and device development companies’ bottom lines all benefit when more patients can access more cures at lower cost.

Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products

Gene and cell therapies offer tremendous potential for treating unmet medical needs; however, successful development of these advanced therapeutic approaches is extremely challenging, largely because of their complexity. Characterizing and quantitating specific structural attributes and assessing criticality of those that influence quality, efficacy and safety, including delivery to target tissues, protein expression in vivo and eventual clinical outcomes, is essential to be able to advance both individual gene therapy candidates and the emerging underlying vector/gene platforms.

How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

The use of artificial intelligence (AI) technologies is poised to have a major strategic impact on focus and differentiation, which will redefine the clinical data review and cleansing process. This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

Reducing the Risks inherent in Emergency medical Contact and Unblinding

All sides agree that patient safety is paramount in the conduct of clinical trials. While focused on patient safety, investigators and sponsors are also mindful of the need to maintain study integrity, to the extent possible.

De-Identification 101

Big data and big privacy can go together. Safely and securely share health data information with the right strategy: de-identification. Learn everything there is to know about the process in Privacy Analytics’ white paper. De-identification takes data-masking to a whole new place–ensuring quality, granular data while minimizing risk of data breach and re-identification. HIPAA compliant, de-identification goes even further to protect sensitive information while maintaining data utility for secondary purposes.

How to Safeguard for PHI

Context is king when it comes to safeguarding Protected Health Information (PHI). As patients, we share many personal details with our care providers. Concerns over who has access to this information and how it may be used can cause us as much worry as our health issues. Effectively safeguarding PHI means knowing who will have access to the data, how it will be stored and what details it contains. In other words, its context for use.

Leveraging the Force - How Social, Mobile, Analytics and Cloud Technologies Are Optimizing Clinical Development

How can the biopharmaceutical industry leverage progressive technology concepts by adopting emerging digital technologies such as social media, mobile, analytics and cloud (SMAC) to optimize the drug development process? This article explores how evolving digital technologies combined with key clinical advancements can optimize the clinical development process.

Part One: Taming Technology Chaos, A Vision of eClinical’s Future

For more than a decade eClinical technologies have been steadily transforming clinical trials for the better. Yet despite delivering improved trial efficiency, the proliferation of diverse tools – clinical trial management systems (CTMS), randomization and trial supply management (RTSM), and electronic data capture (EDC) to name just a few – has also produced a ‘technology chaos’ as users and vendors struggle to knit the new tools into comprehensive solutions. To a large extent this isn’t surprising. Technology adoption across most industries, especially operational technologies, follows a similar pattern.

5 Ways to Improve Spirometry Quality in a Clinical Trial

In the experience of the authors of this review, a significant portion of spirometry data in clinical trials is of inadequate or questionable quality. The aim of this whitepaper is to describe and explain the main quality issues encountered in clinical trials whilst exploring mitigation actions that reduces these issues.

From Convergence Vision to Reality

Yet despite delivering improved trial efficiency, the proliferation of diverse tools – clinical trial management systems (CTMS), randomization and trial supply management (RTSM), and electronic data capture (EDC) to name just a few – has also produced a ‘technology chaos’ as users and vendors struggle to knit the new tools into comprehensive solutions. To a large extent this isn’t surprising. Technology adoption across most

Why Monitoring Is More Than Just SDV

Sending armies of site monitors out to conduct 100 percent source document verification (SDV) at every investigative site is not the answer for ensuring data quality, nor is it an efficient use of resources. Furthermore, clinical monitoring entails much more than just SDV.

Comply or Perish: Maintaining 21 CFR Part 11 Compliance

The biggest challenges of Life Sciences companies today are maintaining a robust product pipeline and reducing time to market while complying with an increasing and evolving multitude of Federal and international regulations. In this paper, we discuss the particular requirements of rule 21 CFR Part 11 and describe how OpenText Regulated Documents built on OpenText Content Server – the leading collaborative knowledge management software from OpenText, enables Life Sciences companies to comply with 21 CFR Part 11.

Global Oncology Trials: Planning For Success

This paper explores several of the upfront areas critical to the success of global oncology trials, including study planning, conducting feasibility and navigating regulatory submissions.

A Stone Unturned: Using Global Pharmacy Data to Improve Trial Planning and Accelerate Recruitment

When you’re making limited headway in solving an intractable and industry-wide issue, what a relief it is to discover that you’ve not yet tried everything…that there are still fresh options open to you. Life science companies struggling to improve the efficiency of clinical trial planning and execution may be encouraged to know that solutions exist to accelerate patient enrollment in their next trial.

Accelerating the Clinical Development Journey with Improved Data Management

The need to improve data management and analysis, make decisions faster to accelerate trial timelines and gain competitive advantages is driving biopharmaceutical and medical device companies to utilize emerging eClinical solutions. The amount of data generated before, during and after a clinical trial has grown exponentially and is often found in legacy systems and applications that were never designed to work together. A new clinical trials data management model must facilitate decision making by unifying data and making it easier to access, archive and share information and collaborate effectively.

Bridging the gap between compliance and innovation
Success in medical device manufacturing requires continual innovation in order to deliver improvements in the quality of patient care. This in turn drives business revenue and profits. At the same time, device manufacturers need to comply with the extensive quality systems regulations as issued by the Food and Drug Administration (FDA) and other regulatory bodies and standards organizations.

Laboratory Management for Clinical and Research NGS Labs
Few can argue that Next Generation Sequencing is having a major impact on genomics research. The progress in this field exceeds even that of computational growth according to Moore’s Law, and this rapid progression will be continuing for years to come. The net result is that more labs are able to afford NGS instruments and to perform high volume sequencing. The adoption of NGS sequencers has presented new challenges in handling requests for services, preparing samples and tracking results, especially given the fluid nature of both the NGS market and the protocols for each instrument.

The Safe Harbor vs Statistical One
To leverage PHI for secondary purposes, an understanding of the different de-identification mechanisms is required. Under the HIPAA, there are two methods for de-identification: Safe Harbor and the Statistical Method (otherwise known as Expert Determination). While both are under HIPAA’s privacy rule, they are not the same. Understanding the difference between these two methods will ensure success when unlocking health data.

Reducing Cycle Time with Digital Transaction Management
This eBook provides best practices to drive digital adoption in life sciences, including how you can: Reduce Cycle Time, Improve Trial Enrollment and Informed Consents, Simplify Operations & Approvals.

DocuSign Life Science Solutions for Regulated Life Science Operations
The pressure has never been greater for life science organizations to shorten the development cycle for new drugs and devices — and to do so while cutting costs and complying with industry regulations like 21 CFR Part 11 and Annex 11. DocuSign makes it easier and more efficient for you to adopt digital approvals, agreements and processes for regulated life science use cases. To fuel your digital success, we have outlined DocuSign’s options to help you implement e-signature and digital platform solutions while adhering to life science regulations: DocuSign Life Sciences Module, DocuSign Signature Appliance, Third Party Industry Credentials and Process Validation

Acquiring Scientific Content
SO CLOSE AND YET SO FAR Is that how many documents seem to you? Indeed, getting what you want—when, where, and how you want it—can be a real uphill battle. It’s a process that can be fraught with difficulties, not the least of which includes the overwhelming volume and complexity of content and the myriad ways of accessing and managing it. And that’s true for everyone involved, from the content licensors to the aggregators to the librarians to the end users.
EDC Buyer’s Guide: How clinical research organizations can find the best fit
Electronic data capture (EDC) systems have become essential technology for clinical trials because they help streamline workflow, increase collaboration, and reduce the costs and resources associated with collecting, storing, and distributing clinical trial data. Although all EDCs deliver some combination of those benefits, selecting the one that best fits an organization’s computing infrastructure, trial types, reporting requirements and more can ensure the organization gets the most out of this essential technology. This paper is intended to help clinical-trial sponsors, CROs and sites navigate the process of EDC vendor selection. Covering the different types of EDCs, differences in features and functionality, and related technologies like eSource and ePRO, the paper provides information and insight buyers can use to make a better-informed purchase decision on this key technology for clinical research.

Using the Cloud to Meet the Urgency of Clinical Trials in the Developing World
Experts say that clinical trials on vaccines and drugs to combat infectious disease outbreaks should be conducted among populations affected by the outbreak, if possible. The lack of resources, including internet infrastructure, in areas of the developing world where outbreaks may occur can make it difficult to set up and manage trials. This whitepaper discusses how research organizations can take advantage of such technologies as cloud-based software, EDC solutions, eSource functionality, and offline data capture to shorten the timeline for trials and thereby speed the arrival of effective treatments to fight outbreaks.

Get the whole story: combine Tm and Tagg with sizing and polydispersity on Uncle Thermal ramp stability measurements
(Tm and Tagg) are well-established methods for ranking proteins and formulations for stability. This data is critical for stability determinations, and ensures that researchers are focusing on winning constructs and formulations. While valuable, there is additional information that is not easily gleaned from single-mode instruments. DLS data from Uncle provides even more data on the same set of samples to fill in the missing pieces.

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Tel: 781-972-1349