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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.