Whitepapers & Special Reports


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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.

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.

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.

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.

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.

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.

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.

 
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.


Whitepapers & Special Reports Archive
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.

Electronic Informed Consent in Clinical Research

Medidata is conducting an ongoing study to better understand the regulatory positions, adoption, and variability regarding eConsent globally. The benefits of eConsent have been well documented, yet there is still concern and uncertainty around regulatory positions. This white paper is the first in a series to provide an overview of findings from the eConsent study, which includes the most recent feedback and guidance from relevant regulatory bodies.

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.


To promote your whitepaper with Clinical Informatics News, please contact:   

Angela Parsons
VP, Business Development 
Tel: 781-972-5467