2017

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Bioanalytical Solutions

Syneos Health

2 GLP-compliant bioanalysis laboratories with robotics and LIMS to provide you with consistent, accurate data 17 audits from regulatory agencies (including FDA, EMA, HC, ANVISA) in past 5 years

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Driving positive change for patients through collaboration and education

pharmaphorum

Change Together – www.changetogether.com – will be presenting a live webinar with leading figures from the patient advocacy community, who will debate how we can drive positive change for patients through collaboration and education. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.

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Effect of Alternate-Day Fasting Among Metabolically Healthy Obese Adults

JAMA Internal Medicine

This randomized clinical trial compares the effects of alternate-day fasting vs daily calorie restriction on weight loss, weight maintenance, and risk indicators for cardiovascular disease.

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CIA Torture as Human-Subjects Research

Research Ethics Blog

In the piece linked below, the author (a professor of sociology at the University of California) argues that modern norms governing human-subjects research are actually stronger, or at least more clear, than those governing government-sanctioned torture. Some of us professionally involved in research ethics governance might not agree that norms of that discipline are beyond debate.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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REMOTE Redux: DTP trials are still hard

Placebo Control

Maybe those pesky sites are good for something after all. It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Trials 40
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Improving commercial decisions with customer relationship network insights

pharmaphorum

Networks of influence are shifting the decision-making process for life sciences companies. It is no longer enough to simply view the profile of a HCP or HCO to understand their value to your organization. For life sciences organizations, there is currently a gap in information, understanding, and digital access to these critical customer networks and relationships.

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UNLEARN. RELEARN. REIMAGINE. Smarter communications through behavioral science

pharmaphorum

How can we create smarter, more effective communications for HCPs and patients? What can be done to challenge the status quo, apply a different mindset to communications, and deliver the best possible patient outcomes? In this webinar, we will discuss how multichannel strategy and behavioural science are natural partners in creating smarter, more meaningful, and more effective communications.

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Improving outcomes through industry partnership - the Cancer Vanguard learnings

pharmaphorum

The Cancer Vanguard is a bold initiative setup to take leadership in the delivery of the National Cancer Strategy – Achieving World-Class Cancer Outcomes published in 2015 with a key aim of designing and implementing new and increasingly patient centric models of care in Cancer that can benefit and be adopted by the wider national cancer system. In summer 2016 the Cancer Vanguard medicines optimisation team launched the ‘Pharma Challenge’ as an opportunity for the pharma and life sciences indust

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Pharma and proactive, preventative healthcare: how to use the pharmacy channel

pharmaphorum

Across Europe, a shift towards greater prevention, earlier diagnosis and treatment is needed in order to contain the growing cost of healthcare. But how can healthcare systems make this transition – and how do pharmaceutical companies play a role in this, while also growing their market? A forthcoming webinar hosted by pharmaphorum with sponsor PHOENIX group looks at how harnessing the data and expertise of pharmacies, and via greater engagement with patients, consumers and shoppers can meet thi

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How to maximise the value of digital in medtech

pharmaphorum

With a wealth of market and regulatory changes impacting the medtech sector, it’s time for digital technology to steer the direction of your future business. This expert webinar will evaluate how to strategically embed digital within your own organisation and explore the challenges and the opportunities for transforming customer relationships, driving commercial outcomes.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Disruption and maturity: the future directions for biologics in healthcare

pharmaphorum

A digital debate analysing the future for biologics in the UK and the factor affecting market access in this territory. Our expert panel will cover a number of key topics including: •Are the savings offered by biosimilars being used to innovate and take advantage of the exciting new biologic technologies or just filling in the NHS potholes? •Will the industry continue to invest in cutting-edge research if the UK is not prepared to fund access to it •In a post-Brexit world how can the UK continue

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Powering pharma’s commercial teams with market access insights

pharmaphorum

Market access is influencing drug development and commercial launch strategy more than ever before, with 85% of prescription drugs in the United States reimbursed through managed care plans. Biopharma companies must take into account a multitude of factors when considering physician prescribing behaviors, and need a more integrated "pull-through" strategy across their teams, from managed markets, to marketing, to field sales.

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The future of the clinical trial – collaboration and patient centricity

pharmaphorum

Growing patient influence combined with new technologies and the requirements of new reimbursement models means clinical research is undergoing rapid transformation. Industry is being compelled to move towards more patient centric solutions to keep up with these changes. With healthcare stakeholders in agreement that patient engagement is key to realising the value of clinical trials, regulators, sponsors, CROs, research funders and publishers are all moving towards more patient-focused models.

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Life sciences promotional content management for speed, compliance and insight

pharmaphorum

The life sciences landscape is moving at a rapid pace, which in turn is increasing the demands on marketers to create innovative, digital content faster while maintaining industry compliance. Veeva Systems recently conducted an annual industry study, focused on content and digital asset management within life sciences. Gleaned from the experiences and opinions of leaders across the life sciences industry, the research uncovers current practices and the industry’s need for more advanced approache

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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When small becomes big: orphan medicines, advances, access and affordability

pharmaphorum

Over the past few years there has been a shift in the European pharmaceutical market landscape, with a rise in specialty medicines for diseases with narrow patient populations. Indeed, QuintilesIMS forecasts that, between 2013 and 2018, 94% of list price value growth will be in specialty medicines – with orphan drugs at the forefront of this trend. On 10 April 2017, QuintilesIMS, in partnership with pharmaphorum presents a unique digital debate, bringing together a panel of senior industry exper

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Unlocking the value of pharmacists to reach the right patients and consumers

pharmaphorum

Pharmacists are highly trained healthcare professionals who have a deep understanding of medicines and daily contact with patients and consumers. This puts them in a unique position in terms of being able to maximise the benefits that patients get from their medicines – however, healthcare systems and pharmaceutical companies frequently overlook this potential.

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Approval and access: Overcoming the final hurdle of drug development

pharmaphorum

2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region. There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic protocols and and details of negotiations with drug manufacturers.

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Training and Learning Solutions

Syneos Health

We take a blended approach to learning rather than a didactic approach; and we conduct interactive workshops, which keep participants interested and motivated.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Biostatistics and Statistical Programming

Syneos Health

Our Biostatistics and Statistical Programming team provide full-service support through all phases of clinical development and commercialization.

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Outcomes of Hospitalized Medicare Beneficiaries Treated by Male vs Female Physicians

JAMA Internal Medicine

This cross-sectional study examines whether patient mortality and readmission rates differ between hospitalized Medicare beneficiaries treated by male or female physicians.

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Oncology and Hematology

Syneos Health

At Syneos Health, we believe that every clinical trial is an opportunity to shorten the distance from lab to life.

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Endocrine and Metabolic

Syneos Health

Small biotechnology companies need a partner who can complement their limited staff and be sensitive to budget restrictions.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Real World and Late Phase

Syneos Health

Within biopharmaceutical development, creating a strong value story is the key to market success.

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Retention metrics, simplified

Placebo Control

[Originally posted on First Patient In ] In my experience, most clinical trials do not suffer from significant retention issues. This is a testament to the collaborative good will of most patients who consent to participate, and to the patient-first attitude of most research coordinators. However, in many trials – especially those that last more than a year – the question of whether there is a retention issue will come up at some point while the trial’s still going.

Trials 40
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The Streetlight Effect and 505(b)(2) approvals

Placebo Control

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question. This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago: This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten its

Drugs 40
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Establishing efficacy - without humans?

Placebo Control

The decade following passage of FDAAA has been one of easing standards for drug approvals in the US, most notably with the advent of “breakthrough” designation created by FDASIA in 2012 and the 21st Century Cures Act in 2016. Although, as of this writing, there is no nominee for FDA Commissioner, it appears to be safe to say that the current administration intends to accelerate the pace of deregulation, mostly through further lowering of approval requirements.

Trials 40
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Jerry Matczak

Placebo Control

Jerry Matczak passed away suddenly last Thursday at the much-too-young age of 54. I can say, without exaggeration, that Jerry embodied pretty much everything I aspire to be in my professional life. The MedCityNews headline called him a “social media guru”, but in reality he was temperamentally the exact opposite of a "guru": He was constantly curious; it seemed that every conversation I had with him was composed mainly of questions.

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Culture, Diversity and Inclusion

Syneos Health

Join the conversation. We recognize exceptional talent and partner with organizations who share that same philosophy, like the Healthcare Businesswomen’s Association (HBA).

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Early Phase

Syneos Health

Initial human data are a critical development milestone on the journey from lab to life.

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Commercialization

Syneos Health

At Syneos Health®, we are able to improve brand performance by leveraging data and insights, accumulated best practices and deep access to therapeutic expertise.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!