Exploring new technology integrations to make research compliance altogether better

Forte Research Systems®

Clinical Research Technologies Compliance and Regulatory Efficient Clinical TrialsSince joining forces a year ago, Advarra and Forte have worked to ensure altogether better research, integrating Advarra’s CIRBI platform and Forte eReg.

Converting Compliance from a Cost Centre to a Critical Success Factor

Journal for Clinical Studies

Maintaining compliance can be a relentless drain on resources. Alternatively, business can make good use of the data collected for… Current features Volume 12 Issue 5

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Personality traits affect shelter at home compliance

Scienmag

People low on openness, neuroticism less likely to comply without strict government policies, study says WASHINGTON – A worldwide survey conducted during the first wave of the COVID-19 pandemic found that people with certain common personality traits were less likely to shelter at home when government policies were less restrictive, according to research published by […]. Medicine & Health Behavior Political Science Public Health Science/Health/Law Social/Behavioral Science

CANbridge Modernizes with Veeva Vault QualityDocs to Support Global Compliance for Clinical Trials

BioTech 365

Vault QualityDocs is helping global pharma CANbridge to improve processes, reduce compliance risk, and expand clinical trials BEIJING–(BUSINESS WIRE)–Veeva Systems (NYSE: VEEV) today announced that CANbridge Pharmaceuticals Inc.,

Improving Patient Compliance and Retention in Oncology Clinical Trials

ERT

In this blog, we explore how, by understanding patients’ preferences and meeting their expectations, sponsors can simplify their participation and improve compliance and retention to accelerate important oncology clinical trials.

Auris Medical Regains Listing Compliance with NASDAQ Minimum Bid Requirement

BioTech 365

NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that it has regained compliance with … Continue reading → GlobeNewswireHamilton, Bermuda, August 20, 2020 – Auris Medical Holding Ltd.

Improve Compliance and Create Transparency with 340B Rebates (Free webinar)

Drug Channels

As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. That’s why I’m especially glad to share today’s guest post from Jeremy Docken, Founder and CEO at Kalderos.

Coverage Analysis: Standard of Care vs What Medicare Covers

Forte Research Systems®

Billing Compliance Budgeting Efficient Clinical Trials Financial ManagementA patient’s standard of care refers to an item or service done as part of their routine care. To address additional assessments outside the participant’s SOC, a coverage analysis is necessary.

Q&A: The New Normal: Considerations for Restarting Research

Forte Research Systems®

In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider when ramping up research in the COVID-19 pandemic’s “new normal.”. General

Diamond Pharma Services Supports GenSight Biologics in Submitting Its First Marketing Authorisation Application, for Ocular Gene Therapy LUMEVOQ

BioTech 365

Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary … Continue reading → Business Wire

Livanta Quality Improvement Organization Innovates to Support Healthcare Providers

BioTech 365

06, 2020 (GLOBE NEWSWIRE) — Livanta recently rolled out innovative technological solutions to assist healthcare providers in attaining compliance with new Medicare regulations. ANNAPOLIS JUNCTION, Md., A Centers for Medicare & Medicaid Services (CMS) Fiscal Year 2021 Final Rule, … Continue reading → GlobeNewswire

Patient Support Services Congress

Drug Channels

Patient Support Services Congress. October 27-29, 2020 | VIRTUAL EVENT (All-Digital Format) www.informaconnect.com/patientsupportservicescongress.

BlueCloud and VirTrial Collaborate to Launch the First Global Training and Certification Program for Telemedicine Best Practices

VirTrial

VirTrial developed the program, using BlueCloud standards, while BlueCloud will provide its global networking infrastructure to Deliver, Distribute, Implement and Track (DDIT ) training competencies and certifications for business and compliance purposes. “We’ll

Role of Pharmacist in Transforming Global Health

Pharma Tutor

Pharmacists strive to eliminate medication errors and ensure strict patient compliance to achieve desired therapeutic outcomes. While dispensing the prescription Pharmacists enhance efficacy and safety of medication by motivating patients for compliance of dosage regimen. Actually it is patient compliance which is important for optimum therapeutic outcome. About Author Dr. R. Thakur. Email: drramsthakur@gmail.com. ABSTRACT.

Accelerating the digital approval process

Pharma Phorum

The coronavirus pandemic has forced a traditionally risk-averse industry tied to legacy systems for regulation and compliance to fully embrace digital solutions in commercial and marketing functions.

New Requirements for Blood Pressure Monitoring in Clinical Trials

ERT

We’ll be hosting two live webinars where you can g ain insights on the draft guidance, and how to reduce data variability and increase patient compliance in blood pressure monitoring. .

EMEA Webinar | New Requirements for Blood Pressure Monitoring in Clinical Trials

ERT

Gain insights on reducing data variability and increasing patient compliance in blood pressure monitoring. EMEA Webinar 09/22 – 8:00 am PT | 11:00 am ET | 5:00 pm CEST.

In the News: August Regulatory and Development Updates

Camargo

Sponsors can mitigate the risk of such interruptions by ensuring that their API suppliers and CMOs have good compliance records with the FDA. Senior Director of Regulatory Compliance and Submissions.

VirTrial Expands Internationally with a Fully Scalable Global Telemedicine Platform and a 31 Country Network of Virtual Trial Capable Research Sites

VirTrial

Scottsdale, AZ (February 4, 2020) – VirTrial today announced its international expansion with a newly appointed International Director of Business Development, a network of virtual trial capable research sites across 31 countries, policies supporting GDPR compliance, and product enhancements that support language translation into any left to right reading language. This model is ideally suited for Phase III/Phase IV trials where patient compliance can be assessed from any location.

OFAC fined US subsidiary of Austrian ERBER Group after misinterpreting US Sanctions

Pharma Business Blog

Aggravating factors considered by OFAC were: – Failing to seek appropriate advice; – No existing compliance program; – “Reckless in actions” to sell to Cuba; – Management knowledge about the transactions; and. – Development of “formal written policies and procedures” to prevent future violations, This case underscores the importance of global companies maintaining a compliance program.

PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team

Pharma Phorum

PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance.

Akron Biotech Signs Agreement With Synairgen plc to Supply Interferon-beta for COVID-19 Treatment

The Pharma Data

19, 2020 06:00 UTC. BOCA RATON, Fla.–(

Hancock: Follow Covid rules or they will get tougher

The Pharma Data

NHS Test and Trace will make regular contact with those isolating to check compliance. But compliance isn’t the only problem. Prosecutions could follow in “high-profile and egregious” cases of non-compliance. Image copyright. PA Media.

PRISYM ID makes new senior appointment to drive further growth

Pharma Phorum

Note to Editors: PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance.

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Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress

Drug Channels

Join Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress to discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress. November 16-17, 2020 | Virtual Event www.informaconnect.com/drug-pricing-transparency. Drug Channels Readers: View the complete agenda and register today.

In the News: September Regulatory and Development Updates

Camargo

Senior Director of Regulatory Compliance and Submissions. Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program.

Survey finds quality control is a major challenge in clinical labeling

Pharma Phorum

This was followed by compliance and then speed and efficiency. This enables companies to manage risk in label production and ensure regulatory compliance.”. Many respondents experience frequent problems and blame human error. Wokingham, United Kingdom — 6 August 2020.

Solutions to instantly measure the impact of process quality

The Pharma Data

Learn how to achieve immediate improvements in key quality performance areas such as document control efficiency, training management compliance, corrective and preventive action effectiveness and human error mitigation.

Leading Microbiologists to meet at SMi’s 10th Annual Pharmaceutical Microbiology Conference

Pharma Phorum

The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation.

How to reach a fully integrated production environment by transforming labs

The Pharma Data

Download this ebook in collaboration with OSTHUS to find out how to increase laboratory productivity and meet compliance standards while ensuring data quality.

ReWalk Robotics announces the Appointment of Randel E. Richner, BSN, MPH to its Board of Directors

The Pharma Data

Richner is an experienced public health policy professional with over 30 years of experience in Medical Devices, Reimbursement Strategy and Health Care Policy. MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel and BERLIN, Oct. 19, 2020 (GLOBE NEWSWIRE) — ReWalk Robotics.

Launching a drug in a pandemic

World of DTC Marketing

They have to talk about the possibility of better outcomes and better compliance.

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Seattle Gummy Company Secures The First (IND) Gummy Drug Approval From FDA

The Pharma Data

Led by founder and CEO, Dr. Connie Wan , SGC redefines a household staple into a drug delivery platform to significantly increase patient’s medication compliance with its convenient and easy to take gummy medications. SEATTLE , Oct.

FDA Recommends Clinical Trial Sponsors Consider Virtual Visits

VirTrial

Serious consideration should be given to assure the safety of trial participants while maintaining compliance with good clinical practice (GCP) and minimizing risks to trial integrity. The FDA recently released new guidance on clinical trials in the face of COVID-19. In their published report, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic , they acknowledged that challenges may arise in ongoing trials.

UK doctors call for tighter rules on coronavirus antibody tests

Pharma Phorum

He said: “If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing.”.

ERT Introduces Industry’s First Fully Compliant Respiratory Solution in Adherence with New ATS/ERS Guidelines

ERT

These enhancements make it the industry’s first respiratory solution to achieve full compliance with standards issued by the American Thoracic Society and European Research Society (ATS / ERS) in 2019.

Rare diseases, repurposing and the role of AI

Pharma Phorum

When a trial is completed, the valuable and extensive data it has produced must be archived – an exercise crucial both to regulatory compliance and to any future efforts at repurposing. This percentage rose to 65% amongst QA, compliance, legal and regulatory professionals.

FDA Q&A: Your Pharmaceutical Manufacturing Inspection Questions Answered

XTalks

Having a good history of compliance with the FDA could help manufacturers avoid import delays.

Decentralized Clinical Trials Enable Participation for Immobile Patients

VirTrial

DCTs enable PIs to maintain patient engagement and conduct remote safety check-ins, electronic questionnaires, and medication compliance via video, text, and email. Clinical trials require a significant commitment from patients, particularly in regard to travel time to research sites for regular visits. Consider the additional patient burden involved in clinical trials for patients with paralysis, dementia, or other conditions that make travel difficult or impossible.

What is the Digital Single Market?

Una Com Pharma

3) Co-ordinated enforcement: Cooperation between those responsible for enforcing the rules locally, at Member state level or EU wide combined with ‘passporting’ (meaning compliance with the rules in one state covers the whole EU) thus increasing confidence for businesses and citizens that they can trade EU wide. And it reduces the costly need to establish compliance systems for multiple countries.