5 Keys to Choosing the Right Healthcare IT Partner

Clinical Trials & REMS in the Time of Corona: FDA & MHRA Advice and Guidance

Pharmacovigilance expert Bart Cobert discusses the FDA and MHRA guidance for non-Corona related clinical trials.

Does Rapid FDA Approval Produce Drug Safety Issues?

Bart Cobert gives his pharmacovigilance point of view on a recent paper on FDA approval timelines and drug safety issues.

Clinitrials.gov Update

Bart Cobert on the importance of publishing clinical trials data and implications on pharmacovigilance.

Pharmacovigilance 2030

This is an interesting article looking at what PV will be in the year 2030.

FDA Draft Guidance on PMRs

Bart Cobert highlights the most important changes in the recently revised FDA draft guidance on PMRs.

Ranitidine – What Happened and What Do We Learn?

Bart Cobert explores several important points to take from the still ongoing signal and safety issue with Renitidine recall.

Going Mobile: Creating Experiences that Matter with the Avaya Mobile Experience

Read how C3i Solutions is leveraging Avaya Mobile Experience to provide better customer experience.

Vaping – A Serious Safety Signal

Bart Cobert discusses the major safety issue in the US on e-cigarettes and vaping.

Importing Canadian Drugs to the US

Bart Cobert covers several issues involved in setting up the proposed "Safe Importation Plan" which aims to allow US consumers to get safe and cheaper drugs.

No-No's in Drug Safety

An overview covering a number of things to avoid doing when it comes to drug safety.

Different Regulatory Actions from Different Agencies

Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.

Contributions of Nurses in Pharmacovigilance and Drug Safety

Dr. Adele Mueller explores the strong patient safety and advocacy responsibility of nurses who work in the pharmaceutical industry.

Reporting and Not Reporting Data

Bart Cobert discusses the importance of clinical safety reporting. Not only is this a legal responsibility but also an ethical one.

Medical Marijuana and Drug Safety

Bart Cobert addresses the use of marijuana for medical purposes and the implications for Drug Safety.

Guide to Causality Assessment

What information should be examined in the study and work up of ADRs to determine whether the reaction is likely due to the drug or not.

Artificial Intelligence in Healthcare – Potential Use Cases

The greatest change AI will bring about in healthcare is the enabling of clinicians to make sense of the mind-boggling amount of patient data being generated every day.

UK and EMA Inspections Update 2019

Bart Cobert reviews the changes and updates happening with UK and EMA inspections.

Voice Interactions – A Channel to Better Health Outcomes

Voice Assistants may just be the key to solving the challenge of patient non-compliance.

Patient Centricity in Clinical Trials

Patient engagement technology is critical to the needs of the pharmaceutical industry, and thus, patient centric clinical trials are the way forward.

Safety Reporting: Why We Do What We Do

We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.

Brexit Update (again)

An update on the status of Brexit and the EMA move to Amsterdam.

Role of Virtual Assistants in Patient Support

The life sciences industry is striving to develop patient engagement through the use of AI-driven virtual assistant services.

Healthcare Transition

Transitioning from Illness Management to Wellness Management: How can Healthcare Make Itself an Active Partner in Consumers’ Lifestyle Transformation?

Confusions in Drug Safety & Pharmacovigilance

Bart Cobert addresses confusing areas in Drug Safety and Pharmacovigilance including Brexit, basic terminology, date formatting and others.

Proactive Patient Engagement for Driving Value-Based Care

Healthcare organizations have a financial incentive to deliver value-based care throughout the entire patient journey. Proactive patient engagement supports this delivery model in several ways.

Language and Translations in PV

Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.

Healthcare on the patient-centricity highway!

Digital healthcare has only now begun to genuinely transform patient experience. These 6 major trends will drive the patient experience in 2018.

EMA and Brexit Yet Again: Part 3

Bart Cobert highlights the ongoing saga with EMA and Brexit. In this post, he elaborates on the lack of a current Brexit deal between the EU and the UK.

3 Keys to Patient Engagement Success

There are 3 keys to success when developing a patient engagement program.

How are Empowered Nurses Changing the Pharma Industry?

Nurses today are in an optimal position to help pharma companies. Dr. Adele Mueller shares how empowering nurses empowers patients.

EMA and Brexit Yet Again: Part 2

Another update from Bart Cobert regarding the ongoing Brexit saga.

EMA and Brexit Yet Again: Part 1

The Brexit saga continues. Here Bart Cobert highlights new Brexit developments with regard to the EMA.

DMCs and SACs

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

What Difference Does 5 Years Make?: Millennial Channel Preference

How have Millennial channel preferences for contacting consumer affairs changed over the past 5 years?

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

Exploring the role of the Medical Monitor in the clinical research process.

Patient Engagement Keys to Success: Focus on the Patient

When developing a patient engagement program, focus on the patient.

Data Security, Protection and the US-EU Privacy Shield: Part 1

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

Going 75 Miles an Hour

Bart Cobert explains the risk to a company when drug safety and PV are not done correctly.

Expanded Access Trials, IITs and Safety Risks

Bart Cobert examines expanded access/compassionate use trials and investigator initiated trials in light of the FDA’s revised guidance, issued in October 2017.

EMA Move – The Details

It’s decided: the EMA is moving to Amsterdam, The Netherlands by March 30, 2019. Less than two years away. Bart Cobert highlights the PV/Drug Safety concerns of the EMA move.

Best Practice: Improving Veeva CRM Support Resolution Rate

How improving your Veeva CRM support resolution rate can lead to increased sales force effectiveness.

FDA Adverse Events Reporting System (FAERS)

FDA operates one of the largest and most complete databases of adverse events on drugs marketed in the US. FAERS data is now easily searchable online.

Is Real-Time Analytics Right for Your Organization?

Big Data has been around for years, but the concept of real-time analytics has remained a challenge. But with current technological innovations, including automation and AI, that's all changing.

Safety of Drugs Bought Abroad or Online

Many US patients are obtaining drugs from online and foreign pharmacies. Bart Cobert examines this trend, and its impact on drug safety.

EU Update: EMA Relocation & EU Inspections

The EU is in turmoil as the Brexit EMA relocation continues to percolate, particularly behind closed doors. Also EU inspections are being discussed.

Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.

Risk Management: Anticipate > Eliminate > Mitigate

Risk. From the time we wake up, we are faced with risks. Knowingly or not, our waking hours are spent trying to either eliminate or mitigate those risks.

Brexit, Again

The UK has given official notice that they will withdraw from the EU. With Brexit seemingly moving ahead, Bart Cobert looks at its effects on the world of pharmacovigilance.

Trust Us, You Need to Know These 5 Contact Center Trends

Contact centers are the face of your brand. They need to understand how to take advantage of current trends, and be prepared for what’s coming next.

When Medical Information Becomes a Drug Safety Issue

Closely-tied Medical Information and Drug Safety departments, with a seamless adverse event intake and hand-off processs, offer better quality control, scalability and risk mitigation.

Drug Safety and AEs in Children

As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.

Phase I Disasters … And Some Good News

Every couple of years, the pharmacology world reads about a phase I trial that has significant problems or is a frank disaster.

Pharmaceutical Training: 3 Guiding Principles for Success

Training pharmaceutical representatives to understand — and maximize the benefits of — software they’re using on the job is a necessary component of any pharmaceutical sales program.

Remote PV Audits & Inspections

The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.

The Clinical ‘Connectors’ for Escalation Services

Soniya Patel highlights the importance of medical escalation procedures during a clinical trial.

Adopting Patient Centricity at Scale: Creating Synergy for Program Success

Susan Mattson & Ed Chase explore some of the areas hindering pharma companies from becoming fully patient-centered, and how to overcome these challenges.

WeChat as IT Support Channel for Pharma in China

Jackie Gong highlights how pharma companies in China are using WeChat as an IT contact center support channel.

Adverse Events: Not Just a Concern for Healthcare

Frank Pettinato discusses the FDA database which catalogs adverse event and product complaint info for foods, dietary supplements, and cosmetics.

CURES Act of 2016 and Drug Safety

A look at the somewhat controversial law was passed in late 2016 known as The 21st Century Cures Act – and its implications for drug safety.

PMCs and PMRs: Some Good News

Bart Cobert looks at the recent FDA report on Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).

Using NPS to Improve the Customer Experience in Japan

A look at Net Promoter Score (NPS), and its use in the Japanese contact center industry

How Precision Medicine is Making Patient Engagement More Personal

Pharma companies continue to develop more individualized treatments. Programs to support this precision medicine approach should be tailored yet adaptive.

Timely Reporting to the FDA

Bart Cobert examines 2 recent cases of late reporting of clinical trial information to the FDA and other federal agencies.

Set the Stage for Patient Engagement Success

What does an effective omnichannel approach for patient engagement look like today, from a strategic and operational perspective?

Pharma’s Practical Next Steps for Social Media

What’s Next: Practical Steps for Pharma's Increased Social Media Participation

FDA’s Drug Safety Report

A look at FDA's recent drug safety report, which outlines their procedures in place to monitor drug safety, called Drug Safety Priorities. Initiatives & Innovation.

Transforming CRM through Speech Recognition

New speech recognition technology is evolving the standard of phone call-based customer service.

Pharma Companies in China Utilize WeChat for Engagement

WeChat provides pharma companies a cost-effective, user-friendly platform to deploy mobile applications and engage the public, HCPs and employees.

PV Inspection Update

Pharmacovigilance inspections by health authorities remain a hot topic for pharma companies.

To Create Successful Adherence Programs, Know Your Patients

Your patient adherence program is only as successful as the patients who are enrolled and engaged. Consider ways to make your programs more accessible, relevant and customizable.

Integrate Social Media into Your Customer Care Service Model

Today’s more advanced social customer care activities require coordination among key stakeholders — namely, marketing, consumer affairs and external brand agencies.

Pharma’s Top 4 Social Media Participation Concerns

Based on a recent survey, these are the Top 4 Social Media Participation Concerns for the industry.

Brexit and Pharmacovigilance

What effect will Brexit have on the world of Pharmacovigilance?

Monitoring Medical Literature for Drug Safety

Monitoring of medical literature for safety signals and adverse events is critical to both veterinary and human PV.

Getting Started in Pharmacovigilance – Part 2

In Part 1 we talked about concepts and starting the preparation for job hunting.  Here are the next steps.

What is Community Support?

There is one trend we've seen lately, however, that is innovative: Community Support.

Getting Started in Pharmacovigilance – Part 1

Interested in a career in Pharmacovigilance?

Using Remote Site Monitoring to Enhance Global Clinical Trial Productivity

How Remote Site Monitoring can enhance the global productivity — and reduce the costs — of a clinical trial.

Regulatory Compliance Challenges in a Global Economy

Life sciences companies are facing more regulatory compliance challenges now than ever before. Selecting the right compliance partner is crucial.

FDA Guidance on Biosimilar Labeling

Bart Cobert reviews the newly published FDA draft guidance for industry on Labeling for Biosimilar Products.

Animal Health 101: Key Components of a Veterinary PV Program

As in the human medical sciences field, the world of veterinary PV is constantly evolving. Explore the 4 main components of an animal health PV program.

EMA GPVP Module V – Risk Management: Draft Revision 2

In February 2016 the EMA released a draft of the revisions for the new version of Module V on Risk Management.

Making Sense of Social Media Conversations

Phil highlights the relevance of social media monitoring and engagement in the healthcare industry.

The French Phase I Trial Disaster

Bart Cobert discusses the lessons learned from the recent Phase I trial disaster in France.

WHAT Are You Wearing? The State of Wearable Health Devices

Last month we rolled out the Red Carpet. Now let’s talk not about WHO we are wearing, but WHAT we are wearing. Namely, wearable health devices.

FDA’s Safety Assessment for IND Safety Reporting Draft Guidance

Bart Cobert examine's the FDA's latest guidance on Safety Assessment for IND Safety Reporting

FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.

Digital Strategies for a Proactive Omni-Channel Contact Center

At CBI’s Bio/Pharma Contact Centers conference, we presented on how social media and digital health can help turn a contact center from re-active to pro-active.

PV Inspections of Contract Service Providers

An update on inspections by governments and health authorities of CROs and other pharma service providers.

EudraVigilance Stakeholder Change Management Plan

EMA Changes to EudraVigilance (EV), ICSR reporting and SUSAR reporting

SAE Reporting for Outsourcing Facilities (Compounders)

Bart Cobert reviews the FDA guidance on AE Reporting for Outsourcing Facilities (Compounders)

Bart's Corner: Coding MedDRA and ICD-10

Comparing Coding MedDRA and ICD-10

Bart's Corner: Danish HA Guide on PV

Industry Trends Shaping the Future of Pharmacovigilance

Patient Segmentation Research Provides Insights into Digital Health's Future

Bart's Corner: Preparing and Coding Expedited Reports

C3i Healthcare Connections Positioned in 2015 Gartner Magic Quadrant

Company recognized in report for third consecutive year

Addressing the Barriers to Adherence Using Integrated Multi-Channel Technology

As the healthcare market evolves, it’s clear that the 3 most common barriers to patient adherence – Cost, Concern, and Commitment -remain.

FDA Draft Guidance on Rare Diseases

5 Market Trends Driving the Adoption of Digital Health

Bart's Corner: Late Expedited Reports to the FDA

Bart’s Corner: The Business of Pharmacovigilance

2015 Medical Information Benchmarking Report

C3i Healthcare Connections recently surveyed medical information professionals regarding such topics as operations, quality assurance, sourcing, content, technology capabilities, reporting, and globalization. The resulting 2015 Medical Information Benchmarking Report includes insights and analysis of the medical information industry.

Bart's Corner: In Memoriam Dr. Kelsey

Compliance, Quality & Cost: Outsourcing Clinical Trial Support

Update on Drug Safety Courses & Certificates

Patient Support and Adherence Programs Crucial for Biologics

Monitoring Medical Literature: EU Changes

The EU and FDA have required Marketing Authorisation Holders (MAHs) to monitor medical literature for adverse drug reactions for many years. The EMA has finally put forth the details of its new system to monitor medical literature for MAHs.

Summer Pharmacovigilance

July and August (in the northern hemisphere) when things often slow down, the weather heats up and folks go on vacation. Sometimes, though not always, drug safety and pharmacovigilance efforts slow down too.

FDA’s May 2015 Draft Guidance for Investigator Initiated Trials / Studies

Industry expert Bart Cobert reviews the FDA's latest draft guidance for Investigator Intiated Trials & Studies

Bart's Corner: Guidelines on EMA Good PV Practices (GVP) April 2015

Bart's Corner: FDA’s New REMS Guidance

Bart's Corner: Drug Safety & Tissue-Based Products FDA Guidance

Social Customer Care: National Champion

Bart's Corner: AE Reporting FDA Draft Guidance

Social Customer Care 2015: Elite Eight

Social Customer Care 2015: Sweet 16

Bart's Corner: MHRA Good PV Practices Updates – Inspections

The Evolving Medical Affairs Landscape: 5 Global Trends

Bart’s Corner: The ISMP Report on Drug Safety Reporting – Part 2

Bart’s Corner: The ISMP Report on Drug Safety Reporting – Part 1

What Can You Learn From Other Industries?

Explaining Drug Safety & PV to Senior Management… and Your Mom!

3 Keys to Handling a Product Recall

Bart’s Corner: Proposed MedWatch Changes

Bart's Corner: REMS Update

Bart’s Corner: PV Crises

Bart's Corner: Drug Safety Stress Tests

Could your drug safety department withstand a crisis or a “perfect storm” that puts severe stress on your department and company?

5 Keys to Choosing the Right Healthcare IT Partner

Seriousness, Expectedness and Investigator Brochures

Pharma’s Next Step: Tapping into Social Media to Support Critical Initiatives

Bart's Corner: Safety Data Exchange Agreements

How Are Tech Innovations Improving the Healthcare Industry?

Saying YES to Excellence this Customer Service Week

Bart's Corner: EU Proposals on Updates for Good PV Practices

Bart’s Corner: Escalating Signals and Safety Issues

Bart’s Corner: Update on EMA Risk Management Plans (RMPs)

Bart's Corner: Medical Literature Review

Bart's Corner: The Sentinel and Mini-Sentinel Initiatives

Bart’s Corner: EU Pharmacovigilance Inspection Update

FDA Webinar on Social Media Guidance

Data Monitoring Committees: Observations & Issues – Part II

5 Best Practices for Pharma Social Media

Data Monitoring Committees: Observations & Issues – Part I

Public Health, Social Media and the Pharmaceutical Industry

Safeguarding Patient Data – Part Two: 5 Tips for Maintaining a Constant Working Posture for Privacy

Bart’s Corner: French Breast Implant Safety Scandal

Safeguarding Patient Data – Part One: More Data, More Opportunities for a Breach

Bart's Corner: EU Regulatory Updates

Exchange Plans’ Hidden Challenge: Co-Insurance

To Outsource or Not To Outsource? That May No Longer Be a Question

Excipients and Inactive Ingredients in Drugs & Drug Safety

Drug Safety/ Pharmacovigilance & Social Media

Adverse Event Data

Off-Label Use & Safety

Safety Items in the News

DIA’s “What Lies Ahead” Document

Outsourcing’s Increasing Role in the New Healthcare Model

Access and Reimbursement in the Post-ACA World

How to Review a PSUR/PBRER

FDA Issues Social Media Guidance for Pharma

Medical Review of Individual Case Safety Reports

Case Processing Deficiencies

Quality (QA QC QMS) Deficiencies

Finish What You Start

Risk

Interim ICSR Reporting in the EU for Marketed Products

Take a Step Back and Look. The World is Changing Around You.

Generic Safety Labeling: FDA’s new regulation – Part 2

Operational Tweaks Can Greatly Reduce PHI Breach Risk

Generic Safety Labeling: FDA’s new regulation – Part 1

The Old Enriched By The New

Following Up on SAEs: How much is enough?

Preparing for the Consumer Impact of Your Recall

Terminology: Signals, Potential Signals, Risks, Identified Risks and Potential Risks

Top 10 Reasons Why Your Brand Should Be On Google+

MedDRA Coding

Innovation in the Contact Center Industry

Medical Safety Hazard Analyses

Product Quality Issues and Drug Safety

Electronic Records in Clinical Trials-Implications for Drug Safety

The Qualified Person for Pharmacovigilance in the EU

Risk Management Plans-RMPs Part 2

Risk Management Plans-RMPs Part 1

SOPs & Other Procedural Documents

Medical Device Reporting

Drug Safety Update Reports (DSURs)

New SAEs on Old Drugs

Reconciliations

EMA Good PV Module 10 Additional Safety Monitoring of Certain Medicines

Delaying, Denying, Limiting, or Refusing a FDA Drug Inspection

Collecting Adverse Events with Social Media

Deharmonization (alas) in Drug Safety

Miscellaneous: EMA Mod 6 revisions; drug-device AEs; getting AEs in clinical trials

EMA Module 16 Draft Risk Minimisation Measures

OTC Safety Reporting

The Pan American Network on Drug Regulatory Harmonization: Working Group on PV. Good PV Practices for the Americas.

Follow Up of SAEs and NSAEs

Quality Management Systems: FDA & EMA Requirements

EU Good PV Module IV PV Audits

EMA Post-Marketing Regulations Q&A March 2013

The UK’s Association of the British Pharmaceutical Industry’s Guidance on AEs & Product Complaints from Social Media

FDA and PBRERs (PSURs)

FDA’s Structured Approach to Benefit Risk Assessment

Risk à la Canadienne

Crowdsourcing, Drug Safety and Internet Searches

Virtual Pharmacovigilance Inspections

Do REMS really work?

UK’s Data Protection in Post-Marketing PV Guidance of February 2013 (Worth reading for Americans & Canadians too!)

EU Module 15 Safety Communications

MHRA’s Summary of PV Systems (SPS) Document

The New EMA Protect ADR Database

MHRA’s Compliance Report

Challenges, Prechallenges, Dechallenges and Rechallenges

Breaking the Blind in Clinical Trials & Reporting to Health Authorities, Investigators & IRBs/Ethics Committees

Drug Safety in France & Underreporting of AEs

FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part 3

FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part 2

FDA’s December 2012 Guidance on IND and BA/BE Reporting – Part I

FDA’s SOP for FDA’s PV Inspectors

Organizations that Deal with Pharmacovigilance and Drug Safety – Part 2 Training & Education

Organizations that Deal with Pharmacovigilance and Drug Safety – Part 1

Source Documents and Data Retention in Drug Safety

The Uppsala Monitoring Centre (UMC)

Pharmacovigilance and Pregnancy

Drug Induced Liver Injury (DILI)

More PV Lessons from the News: Roche

Injectable Steroids, Monster Energy and Predicting Earthquakes: Lessons For Drug Safety

Pharmacovigilance Fees?

Back to the Basics in PV

FDA's Internal SOP on How To Do An NDA Safety Review Part 3

FDA's Internal SOP On How To Do An NDA Safety Review Part 2

The FDA's Internal SOP On How To Do An NDA Safety Review Part 1

What Is The Right Size For A Safety Database?

The Wave – EMA’s New PSUR-PBRER

New EU Draft Guideline on Pharmacovigilance Inspections “We are here to help you…”

Social CRM in Healthcare: New millennial challenges in a ponderous regulatory environment

The Year In Customer Care

Mister. Can You Spare Some Change?

On The Way to SOCAP Annual Conference

I'm on my way to San Francisco for the annual conference of the Society of Consumer Affairs Professionals (SOCAP). Historically, the content of this conference, and the attendees, has been very focused on in-the-trenches issues that consumer affairs – a unique band of customer service people – professionals deal with day to day. Such topics have included crisis management, adverse events, handling product recalls and performance management metrics. That model is about to erupt; giving way to what I think will launch this organization, and its members, into a whole new strata.

Things Aren't Always What They Appear

Channel Your Energy

Does Influence Matter In Customer Service?

Tree Frogs & The Social Ecosystem