#pharmacovigilance companies

[chemxpert]

Why is Data Critical in Life Sciences and the Emerging Trends in 2024

The life  sciences industry covers sectors such as pharmaceuticals, biotechnology, healthcare, and medical devices, and the sector has been rapidly evolving in the last few years based on the interaction of  data analytics, AI, and other corresponding digital technologies. The growth of precision medicine, a desire for better efficiency in drug development, and a growing focus on patient outcomes are part of the reason why data has become so critical to innovation in the life sciences industry today.

[medvoice]

Pharmacovigilance Services in USA | MedVoice

Pharmacovigilance Services in USA | MedVoice Empower your drug discovery process, enhance research accuracy, and elevate product quality with MedVoice's meticulous pharmacovigilance services. Pharmacovigilance Services, Pharmacovigilance Solutions, Pharmacovigilance Services Providing Company, Pharmacovigilance In USA

[lambdatherapeutic]

Lambda is one of the best Drug Safety and Pharmacovigilance services to our regional customers as per client requirements. Our teams are focused on safety in clinical trials and other activities and are ready to help with your project.

[bobv48-blog]

Paul Hennessy/SOPA/Getty Images

June 14, 2023

Horowitz: Confidential Pfizer document shows the company observed 1.6 million adverse events covering nearly every organ system

Daniel Horowitz

Over 10,000 categories of nearly 1.6 million adverse events – many of them serious and debilitating – brought to you by Pfizer!

You might not have heard it in the news, but in recent months, Pfizer’s pharmacovigilance documents requested by the European Union’s drug regulator, the European Medicines Agency, have been released. They show that Pfizer knew about a sickening level of injury early on. An August 2022 document shows that the company already had observed the following scope of vaccine injury:

508,351 individual case reports of adverse events containing 1,597,673 events;

One-third of the AEs were classified as serious, well above the standard for safety signals usually pegged at 15%;

Women reported AEs at three times the rate of men;

60% of cases were reported with either “outcome unknown” or “not recovered,” so many of the injuries were not transient;

Highest number of cases occurred in the 31-50 year age group, and 92% did not have any comorbidities, which makes it very likely it was the vaccine causing such widespread, sudden injury.

These numbers alone suggest that all COVID shots should be defunded and Congress must immediately remove liability protections from the manufacturers. But a more recent document released by the Europeans is even more devastating, because it breaks down the 1.6 million adverse events observed by Pfizer by category and subcategory of ailment and injury.

The 393-page confidential Pfizer document, dated Aug. 19, 2022, shows that Pfizer observed over 10,000 categories of diagnosis, many of them very severe and very rare. For example:

Pfizer was aware of 73,542 cases of 264 categories of vascular disorders from the shots. Many of them are rare conditions.

There were hundreds of categories of nervous system disorders, totaling 696,508 cases.

There were 61,518 AEs from well over 100 categories of eye disorders, which is unusual for a vaccine injury.

Likewise, there were over 47,000 ear disorders, including almost 16,000 cases of tinnitus, which even Mayo Clinic researchers observed as a common but often devastating side effect early on.

There were roughly 225,000 cases of skin and tissue disorders.

There were roughly 190,000 cases of respiratory disorders.

Disturbingly, there were over 178,000 cases of reproductive or breast disorders, including disorders you wouldn’t expect, such as 506 cases of erectile dysfunction in men.

Very disturbingly, there were over 77,000 psychiatric disorders observed following the shots, lending credence to Dr. Peter McCullough’s research observing case studies showing psychosis correlating with vaccination.

3,711 cases of tumors – benign and malignant

Of course, there were almost 127,000 cardiac disorders, running the gamut of about 270 categories of heart damage, including many rare disorders, in addition to myocarditis.

There were over 100,000 blood and lymphatic disorders, for both of which there’s a wealth of literature linking them to the spike protein.

When reading what Pfizer knew early on juxtaposed to independent studies, it’s clear that nobody could have mistaken most of these AEs for mere incidental ailments. Here is a list of 3,129 case studies chronicling vaccine injury in every organ system observed in this Pfizer document.

What is so jarring is that there are hundreds of very rare neurological disorders that reflect something so systemically wrong with the shots, a reality that was clearly of no concern to the manufacturers and regulators alike. One of the infamous cases of vaccine injury was Maddie de Garay, an Ohio teen who became disabled for life immediately after participating in the Pfizer clinical trial. Her story is chronicled in chapter 16 of my book. I checked this confidential document and found that they knew of 68 cases of her rare diagnosis, chronic inflammatory demyelinating polyneuropathy.

[alpexpharma]

Pharma Company Best Standard to Follow - Alpex Pharma

Pharmaceutical companies are subject to various regulations and standards to ensure the safety, efficacy, and quality of their products. Here are some of the best standards that pharmaceutical companies should follow:

Good Manufacturing Practices (GMP): GMP is a set of regulations that ensure that pharmaceutical products are consistently produced and controlled according to quality standards. Compliance with GMP is mandatory for pharmaceutical manufacturers in many countries.

Good Clinical Practice (GCP): GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.

International Organization for Standardization (ISO): ISO is a set of international standards for quality management systems. ISO 9001:2015 is a specific standard for the pharmaceutical industry that helps ensure that products and services consistently meet customer requirements and regulatory requirements.

Pharmacovigilance: Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Pharmaceutical companies are required to have a pharmacovigilance system in place to monitor the safety of their products.

Ethical Marketing: Pharmaceutical companies are expected to follow ethical marketing practices and adhere to the principles of the World Health Organization (WHO) Ethical Criteria for Medicinal Drug Promotion.

Environmental Sustainability: Pharmaceutical companies should consider the environmental impact of their products and operations, and strive to reduce their carbon footprint and waste.

Adherence to these standards can help ensure that pharmaceutical products are safe, effective, and of high quality, and that companies operate in an ethical and sustainable manner.

[missus-me]

Well actually…. (adjusting my nerd glasses), that‘s not exactly whats happening here. Pharma companies are obligated by law to follow up on adverse events which could be related to the use of their products. This is called pharmacovigilance and very important to help us find out how safe a drug really is. Drugs are tested in clinical trials, which are usually relatively small and only include a subsample of the people who later use the drug in real life. That means we can miss a lot of adverse events, either because they pccur rarely or because we they only happen in a suset of people who have not been included in the clinical trial.

If you work for a pharma company, you have to report any adverse event you encounter. And the companies usually look through social media mention of their products. The follow up is very time consuming but also IT SAVES LiFES! Often the data collected from those types of reports can lead to an adaption to how a drug is prescribed and to label changes.

Which means someone in the PV departement of Allegra had the unglamourous job to follow up on this shit post to find out if it was based on an actual experience.

tldr: report all adverse events to save lifes and annoy pharma companies.

[clinfinitesolution]

The Growth of Contract Research Organizations (CROs) in India 

The Growth of Contract Research Organizations (CROs) in India 

Introduction: 

Contract Research Organizations (CROs) play an important role in bridging the research, development, and commercialization gaps in the rapidly developing global pharmaceutical and biotechnology industries. These businesses offer outsourced research services to pharmaceutical, biotechnology, and medical device companies, allowing them to streamline operations, cut expenses, and concentrate on their core capabilities. India, with its unique characteristics, has emerged as a key competitor in the global CRO industry, providing high-quality services at cheap prices. 

The Evolution of CROs in India

Over the last two decades, India has developed as a major participant in the global CRO business, thanks to its unique combination of cost-effectiveness and skilled labor. The journey began in the early 2000s, when India's pharmaceutical sector first gained international attention for its generic medication production skills. As the sector grew, CROs gained a footing by exploiting India's competence in clinical research and regulatory affairs. Today, India is home to many CROs that provide world-class services to worldwide clientele. 

Key Drivers Behind the Growth of CROs in India

Several factors have contributed to India’s ascent as a global hub for contract research organizations:

Skilled Workforce: India boasts a vast pool of highly qualified professionals, including scientists, researchers, and healthcare experts, proficient in clinical and preclinical research.

Cost Advantages: The cost of conducting clinical trials and research in India is significantly lower compared to developed countries, making it an attractive destination for outsourcing.

Pharmaceutical Ecosystem: India’s established pharmaceutical industry provides a solid foundation for CROs, enabling synergies in research and development.

Regulatory Support: Government initiatives and policies have streamlined regulatory processes, encouraging foreign investments in the CRO sector.

Services Offered by Indian CROs

Indian CROs offer a comprehensive range of services, catering to every stage of the drug development lifecycle. These include:

Clinical Trials Management: Conducting Phase I to Phase IV trials with a focus on efficiency and adherence to international standards.

Bioequivalence Studies: Ensuring that generic drugs meet regulatory requirements.

Preclinical Research: Providing toxicology and pharmacokinetics studies to support early-stage drug development.

Data Management: Offering robust data collection, analysis, and reporting systems.

Pharmacovigilance: Monitoring and ensuring drug safety post-market approval.

Regulatory Support: Assisting with regulatory submissions and compliance with global standards.

Advantages of Choosing Indian CROs

Collaborating with Indian CROs offers a multitude of benefits to global pharmaceutical and biotech companies:

Cost-Effectiveness: Lower operational and labor costs result in significant savings for sponsors.

Diverse Patient Pool: India’s vast and diverse population provides access to a wide range of patients for clinical trials, speeding up recruitment processes.

Quality Standards: Indian CROs adhere to stringent international regulations, including those of the FDA and EMA, ensuring high-quality outcomes.

Challenges Faced by CROs in India

Despite the remarkable growth, Indian CROs face certain challenges that need to be addressed to sustain their momentum:

Regulatory Complexities: Delays and inconsistencies in regulatory approvals can hinder project timelines.

Competition: Emerging markets like China and Eastern Europe pose stiff competition to Indian CROs.

Ethical Concerns: Ensuring ethical standards in clinical trials, particularly in vulnerable populations, remains a critical focus.

Future Prospects: The Road Ahead for CROs in India

The future of CROs in India looks promising, with new opportunities on the horizon driven by innovation and global demand. Key trends shaping the industry include:

Technological Advancements: Integration of AI and machine learning in drug discovery and clinical trials is transforming the industry.

Focus on Biosimilars: As the demand for biosimilars grows, Indian CROs are uniquely positioned to lead this space.

Personalized Medicine: Advancements in genomics are paving the way for research in personalized medicine, presenting new avenues for CROs.

Global Collaborations: Partnerships with international pharmaceutical companies are expected to boost India’s CRO industry further.

Conclusion:

India's expanding position in the CRO industry demonstrates its importance in promoting global healthcare and drug development. With its qualified workforce, economic advantages, and emphasis on quality, India is expected to remain a popular destination for outsourcing research services. As the industry evolves and adapts to new trends, Indian CROs are well-positioned to lead the global market, making substantial contributions to the discovery of innovative and life-saving treatments.

[chemxpert]

Unlocking Pharma Insights : Chemxpert Database for Compliance & Market Access

Explore the latest pharma industry trends and streamline your compliance efforts with Chemxpert Database. Access critical resources from the FDA website to stay compliant with GMP in the pharmaceutical industry. Harness the power of data analytics in the pharmaceutical industry to optimize manufacturing and distribution. Simplify pharmaceutical market access strategies and stay ahead in the competitive landscape with Chemxpert’s comprehensive solutions. Your go-to tool for staying compliant and competitive!

[medipharmsolutions11]

Aggregate reporting

Aggregate reporting is a key component of pharmacovigilance, focusing on the periodic analysis and evaluation of drug safety data. It involves the compilation of safety information from multiple sources, such as clinical trials, post-marketing surveillance, and adverse event reports. The goal is to identify trends, patterns, and potential risks associated with a drug or medical product over time. Common types of aggregate reports include Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). These reports help regulatory authorities and pharmaceutical companies ensure patient safety and maintain compliance with global safety standards.

[lambdatherapeutic]

Lambda's Bioavailability/Bioequivalence Studies offer global access to 800+ clinical beds inclusive of 85+ specialized beds designed for specific studies. Robust recruitment & housing options enable us to provide customized sponsor/study requirements. Till date, over 50 successful inspections by leading regulatory agencies across all Lambda facilities have been completed.

[globalinsightblog]

Pharmacovigilance & Drug Safety Software Market: $7.5B in 2023 to $15.2B by 2033, 7.2% CAGR

Pharmacovigilance and Drug Safety Software Market focuses on developing and deploying software solutions to enhance the monitoring, detection, assessment, and prevention of adverse effects associated with pharmaceutical products. These tools include case data collection, signal detection, risk management, and regulatory compliance software, which help healthcare providers and pharmaceutical companies improve drug safety and efficacy while adhering to stringent regulatory standards.

To Request Sample Report: https://www.globalinsightservices.com/request-sample/?id=GIS25797 &utm_source=SnehaPatil&utm_medium=Article

The market is experiencing robust growth, driven by increased regulatory scrutiny and the need for efficient data management. The cloud-based software segment leads the market, thanks to its scalability and cost-effectiveness. The on-premise software segment follows, serving organizations that prioritize data security and control. Regionally, North America dominates due to advanced healthcare infrastructure and stringent regulatory requirements, while Europe stands as the second most significant region, supported by a strong emphasis on patient safety and a well-established pharmaceutical industry.

The United States leads, benefiting from a high concentration of pharmaceutical companies and technological advancements. Germany follows closely, driven by its robust healthcare system and proactive pharmacovigilance initiatives. The market’s growth is further fueled by innovations in artificial intelligence and machine learning, enhancing the accuracy and efficiency of drug safety assessments.

Market Segmentation

Type: On-premise, Cloud-based, Hybrid

Product: Issue Tracking Software, Fully Integrated Software, Adverse Event Reporting Software, Drug Safety Audits Software, Risk Management Software, Signal Detection Software

Services: Managed Services, Professional Services, Consulting, Training and Support, Implementation Services

Technology: Artificial Intelligence, Machine Learning, Natural Language Processing, Blockchain, Automation

Component: Software, Services

Application: Pharmaceutical Companies, Biotechnology Companies, Contract Research Organizations, Business Process Outsourcing Firms

Deployment: Cloud, On-premise

End User: Pharmaceutical Industry, Biotechnology Industry, Contract Research Organizations, Healthcare Providers

Module: Adverse Event Reporting, Drug Safety Audits, Risk Management, Signal Detection, Case Data Management

In 2023, the market exhibited substantial growth, with the adverse event reporting segment commanding the largest market share at 45%, followed by drug safety audits at 30%, and risk management systems at 25%. The dominance of adverse event reporting is due to the increasing need for efficient data management and regulatory compliance.

Key players in this market include Oracle Corporation, ArisGlobal, and Ennov Solutions Inc. Oracle Corporation leads with its comprehensive suite of pharmacovigilance solutions, while ArisGlobal focuses on innovation and user-friendly interfaces.

The competitive landscape is shaped by stringent regulatory requirements, such as the FDA’s post-market surveillance mandates and the EMA’s pharmacovigilance guidelines. These regulations necessitate continuous software updates and enhancements, driving market innovation. Future projections indicate a steady growth trajectory, with an anticipated 10% CAGR by 2033, fueled by the increasing adoption of AI and machine learning for predictive analytics in drug safety.

Despite the optimistic outlook, challenges such as data privacy concerns and high implementation costs may impact market expansion. However, the integration of cloud-based solutions and the rise of emerging markets present significant opportunities for growth.

#Pharmacovigilance #DrugSafety #AIinHealthcare #MachineLearning #CloudSoftware #PatientSafety #RegulatoryCompliance #PharmaceuticalIndustry #HealthcareInnovation #AdverseEventReporting #RiskManagement #DataManagement #OracleCorporation #ArisGlobal #EnnovSolutions

[gxp-auditing-blog]

Different Types of GxP Services

GxP services in the UK encompass various quality and compliance practices designed to ensure that life sciences organizations, including pharmaceutical, biotechnology, and medical device companies, adhere to strict regulatory requirements. GxP stands for Good [X] Practice, where "X" can represent different areas of focus. Below are the common types of GxP services offered in the UK:

1. Good Manufacturing Practice (GMP)

Focuses on ensuring the quality and safety of products during manufacturing processes.

Includes services like GMP audits, validation of manufacturing processes, equipment qualification, and batch record review.

2. Good Laboratory Practice (GLP)

Ensures the quality and integrity of non-clinical laboratory testing data.

Covers services such as laboratory audits, SOP development, and training on GLP compliance.

3. Good Clinical Practice (GCP)

Maintains ethical and scientific quality standards for designing, conducting, and reporting clinical trials.

Services include GCP audits, clinical trial monitoring, and regulatory compliance support.

4. Good Distribution Practice (GDP)

Focuses on ensuring the quality of pharmaceutical products during storage and distribution.

Services include supply chain audits, temperature-controlled logistics validation, and GDP training.

5. Good Pharmacovigilance Practice (GVP)

Relates to monitoring the safety of medicines and managing adverse drug reactions.

Services include pharmacovigilance audits, risk management plan development, and compliance monitoring.

6. Good Documentation Practice (GDP) (distinct from Good Distribution Practice)

Refers to maintaining accurate and consistent documentation across processes.

Services include document control system setup, record management, and training on documentation standards.

7. Good Automated Manufacturing Practice (GAMP)

Focuses on the use of automated systems in manufacturing processes to ensure compliance.

Services include computer system validation (CSV), software qualification, and risk assessments.

8. Good Clinical Laboratory Practice (GCLP)

Combines aspects of GLP and GCP to ensure high-quality laboratory services supporting clinical trials.

Services include laboratory setup, accreditation support, and compliance training.

9. Good Regulatory Practice (GRP)

Ensures compliance with local and international regulatory requirements.

Services include regulatory strategy development, dossier preparation, and submission management.

These GxP services are integral to maintaining the UK's reputation for high standards in life sciences and healthcare, ensuring that products and processes meet stringent safety, efficacy, and quality