A new peer-reviewed article co-authored by several Cytel scientists re-examines the way in which adaptive trials are designed and implemented within the oncology space. The wide ranging paper spans numerous topics including data considerations, statistical considerations, the commercial and […]
Specialty Pharmacy Virtual Technology Adoption on the Rise
A September 2020 survey of nearly 100 specialty pharmacy and home infusion providers from SmartBrief and Citus Health reveals new trends in specialty pharmacies adoption of virtual patient support during the COVID-19 crisis and beyond. Learn what your peers are saying and why those specialty […]
Clinical Trials Have Changed. Has Your Tech Strategy?
The COVID-19 pandemic drove 45% of clinical trial sites to transition patients from in-person to remote visits using virtual trial solutions. Disruptions preventing or limiting site access to patients, monitors, and CRAs are propelling long-lasting changes in the research industry, supported by […]
Beyond COVID-19: Life sciences reimagined
Every biopharma function has had to evaluate and adapt its roles and responsibilities almost overnight. So, how do we navigate the uncertain landscape ahead? We surveyed over 550 biopharma executives - from R&D to commercial – to gain practical insights on the current state and long-term outlook […]
How Real-World Evidence Can Support Adoption of New Technology
The use of real-world evidence (RWE) in healthcare decision-making could significantly improve patient outcomes, improve care, reduce costs, and boost efficiencies in health care systems. Increasing acceptance of the value of real-world evidence — along with the support of its use by the U.S. […]
Interventional Studies
Evidera’s interventional study team, made up of dedicated peri- and post-approval experts, can design and execute efficient, fit-for-purpose studies that help you meet regulator requirements and achieve optimal commercialization. With deep knowledge of post-market requirements and endpoints, our […]
Virtual Expanded Access Program Providing Breast Cancer Patients Early Access to Treatment During the COVID-19 Pandemic
During the COVID-19 pandemic, a large pharmaceutical client required an alternative solution to on-site visits for an early access program. The solution had to be rapidly deployed to speed access to an investigational treatment for breast cancer patients. This was critically important due to their […]
Pediatric Drug Development: Trends and Perspectives in the United States
Pediatrics started to emerge as a medical specialty in the United States (US) with the founding of the American Pediatric Society in 1888. However, the field of pediatrics as we know it today originated with the establishment of the American Academy of Pediatrics and American Board of Pediatrics in […]
Can Clinical Studies Go Virtual?
COVID-19 has significantly impacted the way we live, work, and play. It has also had a significant impact on clinical care and real-world research. When the pandemic began, routine clinical care was largely put on hold and then shifted to virtual visits when feasible. The same can be said of […]
ICER’s impact on payer decision making
In the absence of a national Health Technology Assessment (HTA) body in the United States, the Institute for Clinical and Economic Review (ICER) has emerged as a leading voice in evaluating healthcare technologies on their clinical and economic value. However, given that there is no mandate to […]
Representation and Diversity in Clinical Trials
For decades, clinical trials have been considered the gold standard in medicine. For regulators, providers, payers, and patients to trust a new treatment, it must first be proven safe and effective in a clinical trial. But clinical trials have historically fallen short in a critical way: They […]
Advisory Boards: The Good, The Bad, and The Ugly
Our philosophy for advisory boards is simple: clearly define and agree on the objective; prepare and rehearse every aspect of an ad board prior to the event. That sounds obvious, but you might be surprised by how many companies don’t do it. Sometimes our clients ask us to help set up and […]
An Initial Framework to Describe and Classify Integrated Scientific Advice Procedures
With the growing availability of Integrated Scientific Advice (ISA) there is a need to describe and classify ISA procedures to support comparisons and identify the value of the differing programs. Evidera has developed an initial and detailed framework to compare formal ISA procedures. A key aim of […]
Ensuring timely dissemination of research: a guide to working as a medical publications professional
The aim of this guide is to provide an overview of medical publications management. As well as explaining the processes and the regulatory environment, we provide a number of profiles from specialist medical publications professionals that give valuable insights into the various different roles […]
Patient Intelligence and Insights Reports
Our analysis, performed by an experienced team of physicians, health analysts, behavior scientists and commercial strategies, results in impactful insight and implications for your business. Findings and insights inform all aspects of the product lifecycle, from clinical development, product […]
Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines
Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these […]
Patient Centricity
Exploring the patient dynamic from different perspectives
The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them. While it seems fairly obvious that drug development is centred on the patient, the truth is that patients were not always an integral part of the […]
How to Excel at Next Generation Trial Execution
The next generation of clinical trials will be faster, more efficient, and produce higher quality patient outcomes. As the spread of COVID-19 puts antiquated processes to the test, one thing is clear—technological transformation is necessary in rising to the challenge of increased trial complexity. […]
Payers: The New Catalysts of Better Health
Create Momentum through Meaningful Intelligence The traditional definition of healthcare is evolving. Care delivery is getting more complex, and several factors are necessitating the move to more vertically-integrated patient care. Care that is focused on holistic well-being, not just episodes of […]
A writer’s role in drug development: a guide to getting started in regulatory medical writing
This guide aims to provide an insight into regulatory medical writing with a focus on drug development as opposed to medical devices, although writers work in both areas. It explores the roles and attributes of the writer, tips on winning your first regulatory writing role and help deciding whether […]
Virtual Medical Conferences: The new normal?
Is the virtual medical conference here to stay? The crowded world of medical conferences was already ripe for change when the COVID-19 pandemic hit. Conference organizers responded quickly, rapidly accelerating their virtual conference offerings to service the scientific needs of the medical […]
How Healthy Are Your Market Access Programs? A guide to performing check-ups on pharmaceutical distribution and patient access programs
Pharmaceutical manufacturers invest countless resources to develop product distribution and patient access programs to maximize product success. But eventually most programs will experience service disruptions, face unforeseen challenges, and receive negative feedback from stakeholders. Why does […]
The Overlooked Patient: How payers can identify, engage and treat the vulnerable populations not participating in their own care
Populations with behavioral health conditions and medical comorbidities can inflate healthcare costs by up to 6.2 times1 - with little to none of those dollars spent on behavioral care. This can result in as much as $68B in avoidable annual costs2. In addition to all that payers are doing to […]
Unlocking the potential of a Chief Outcomes Officer
A chief outcomes officer could play a vital role in connecting providers, health plans and patients. However, fully implementing a new role within your organization can prove challenging. This white paper illustrates how this emerging role can be integrated through: Standardization and […]
Pharma’s path for digital health solutions
Navigating the commercial, data and regulatory challenges Pharma's approach to digital healthcare products is maturing. The era of experimental pilot apps is being replaced with a more sophisticated and strategic approach. Pharma firms are now looking to align digital health products with their […]
Gartner 2020 Magic Quadrant for Data Science + Machine Learning Platforms
There’s plenty of hype around artificial intelligence, machine learning, and data science, but we are confident you can cut right through that in Gartner’s latest report, “2020 Magic Quadrant for Data Science and Machine-Learning Platforms.” We believe you will learn about: Why platforms […]
How Are Changing Reimbursement Models Affecting Denials?
Traditional payment models are being replaced as the patient becomes a more integral part of the payment picture due to the overall shift to greater patient responsibility. But this may mean challenges in the area of patient access. How does this affect denials? Click here for more information […]
Regulation and Market Climate Force the Issue of CDM Prices
As the regulatory and consumer focus on price transparency increases, so too has the pressure from Centers for Medicare & Medicaid Services (CMS) on hospitals to maintain accurate pricing. Every chargemaster, no matter how compliant, must be continually monitored to maintain rational, […]
The Missing C-Suite Role
How a Chief Outcomes Officer could reduce administrative variability and help consumers find the care they need Few health care organizations or consumers feel they’ve achieved their goals of improved outcomes, lower cost and higher satisfaction. And clinicians are overwhelmed with administrative […]
Patient- or Participant-Generated Registries
Patient registries can provide important, real-world evidence to inform health decisions made by patients, consumers, providers, as well as regulatory agencies and payers. Many patient registries are sponsored by professional associations, academic institutions, healthcare organizations, or […]
