Update — December 7, 2014. – Evidence-based medicine (EBM) is not working for many reasons, for example: 1. Incorrect in their foundations (paradox): hierarchical levels of evidence are supported by opinions (i.e., lowest strength of evidence according to EBM) instead of real data collected from different types of study designs (i.e., evidence). http://dx.doi.org/10.6084/m9.figshare.1122534 2. The effect of criminal practices by pharmaceutical companies is only possible because of the complicity of others: healthcare systems, professional associations, governmental and academic institutions. Pharmaceutical companies also corrupt at the personal level, politicians and political parties are on their payroll, medical professionals seduced by different types of gifts in exchange of prescriptions (i.e., bribery) which very likely results in patients not receiving the proper treatment for their disease, many times there is no such thing: healthy persons not needing pharmacological treatments of any kind are constantly misdiagnosed and treated with unnecessary drugs. Some medical professionals are converted in K.O.L. which is only a puppet appearing on stage to spread lies to their peers, a person supposedly trained to improve the well-being of others, now deceits on behalf of pharmaceutical companies. Probably the saddest thing is that many honest doctors are being misled by these lies created by the rules of pharmaceutical marketing instead of scientific, medical, and ethical principles. Interpretation of EBM in this context was not anticipated by their creators. “The main reason we take so many drugs is that drug companies don’t sell drugs, they sell lies about drugs.” ―Peter C. Gøtzsche “doctors and their organisations should recognise that it is unethical to receive money that has been earned in part through crimes that have harmed those people whose interests doctors are expected to take care of. Many crimes would be impossible to carry out if doctors weren’t willing to participate in them.” —Peter C Gøtzsche, The BMJ, 2012, Big pharma often commits corporate crime, and this must be stopped. Pending (Colombia): Health Promoter Entities (In Spanish: EPS ―Empresas Promotoras de Salud).

1. Misinterpretations New technologies or concepts are difficult to understand in the beginning, it doesn’t matter their simplicity, we need to get used to new tools aimed to improve our professional practice. Probably the best explanation is here in these videos (credits to Antonio Villafaina for sharing these videos with me). English https://www.youtube.com/watch?v=pQHX-SjgQvQ&w=420&h=315 Spanish https://www.youtube.com/watch?v=DApozQBrlhU&w=420&h=315 ----------------------- Hypothesis: hierarchical levels of evidence based medicine are wrong Dear Editor, I have data to support the hypothesis described in the title of this letter. Before rejecting the null hypothesis I would like to ask the following open question:Could you support with data that hierarchical levels of evidence based medicine are correct? (1,2) Additional explanation to this question: – Only respond to this question attaching publicly available raw data.– Be aware that more than a question this is a challenge: I have data (i.e., evidence) which is contrary to classic (i.e., McMaster) or current (i.e., Oxford) hierarchical levels of evidence based medicine. An important part of this data (but not all) is publicly available. References
2. Ramirez, Jorge H (2014): The EBM challenge. figshare. http://dx.doi.org/10.6084/m9.figshare.1135873
3. The EBM Challenge Day 1: No Answers. Competing interests: I endorse the principles of open data in human biomedical research Read this letter on The BMJ – August 13, 2014.http://www.bmj.com/content/348/bmj.g3725/rr/762595Re: Greenhalgh T, et al. Evidence based medicine: a movement in crisis? BMJ 2014; 348: g3725. _ Fileset contents Raw data: Excel archive: Raw data, interactive figures, and PubMed search terms. Google Spreadsheet is also available (URL below the article description). Figure 1. Unadjusted (Fig 1A) and adjusted (Fig 1B) PubMed publication trends (01/01/1992 to 30/06/2014). Figure 2. Adjusted PubMed publication trends (07/01/2008 to 29/06/2014) Figure 3. Google search trends: Jan 2004 to Jun 2014 / 1-week periods. Figure 4. PubMed publication trends (1962-2013) systematic reviews and meta-analysis, clinical trials, and observational studies.
   Figure 5. Ramirez, Jorge H (2014): Infographics: Unpublished US phase 3 clinical trials (2002-2014) completed before Jan 2011 = 50.8%. figshare.http://dx.doi.org/10.6084/m9.figshare.1121675 Raw data: "13377 studies found for: Completed | Interventional Studies | Phase 3 | received from 01/01/2002 to 01/01/2014 | Worldwide". This database complies with the terms and conditions of ClinicalTrials.gov: http://clinicaltrials.gov/ct2/about-site/terms-conditions Supplementary Figures (S1-S6). PubMed publication delay in the indexation processes does not explain the descending trends in the scientific output of evidence-based medicine. Acknowledgments I would like to acknowledge the following persons for providing valuable concepts in data visualization and infographics:
4. Maria Fernanda Ramírez. Professor of graphic design. Universidad del Valle. Cali, Colombia.
5. Lorena Franco. Graphic design student. Universidad del Valle. Cali, Colombia. Related articles by this author (Jorge H. Ramírez)
6. Ramirez JH. Lack of transparency in clinical trials: a call for action. Colomb Med (Cali) 2013;44(4):243-6. URL: http://www.ncbi.nlm.nih.gov/pubmed/24892242
7. Ramirez JH. Re: Evidence based medicine is broken (17 June 2014). http://www.bmj.com/node/759181
8. Ramirez JH. Re: Global rules for global health: why we need an independent, impartial WHO (19 June 2014). http://www.bmj.com/node/759151
9. Ramirez JH. PubMed publication trends (1992 to 2014): evidence based medicine and clinical practice guidelines (04 July 2014). http://www.bmj.com/content/348/bmj.g3725/rr/759895 Recommended articles
10. Greenhalgh Trisha, Howick Jeremy,Maskrey Neal. Evidence based medicine: a movement in crisis? BMJ 2014;348:g3725
11. Spence Des. Evidence based medicine is broken BMJ 2014; 348:g22
12. Schünemann Holger J, Oxman Andrew D,Brozek Jan, Glasziou Paul, JaeschkeRoman, Vist Gunn E et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies BMJ 2008; 336:1106
13. Lau Joseph, Ioannidis John P A, TerrinNorma, Schmid Christopher H, OlkinIngram. The case of the misleading funnel plot BMJ 2006; 333:597
14. Moynihan R, Henry D, Moons KGM (2014) Using Evidence to Combat Overdiagnosis and Overtreatment: Evaluating Treatments, Tests, and Disease Definitions in the Time of Too Much. PLoS Med 11(7): e1001655. doi:10.1371/journal.pmed.1001655
15. Katz D. A-holistic view of evidence based medicinehttp://thehealthcareblog.com/blog/2014/05/02/a-holistic-view-of-evidence-based-medicine/ ---

The Pharmaceutical Intermediates market plays a crucial role in the global pharmaceutical industry, acting as essential building blocks in the synthesis of active pharmaceutical ingredients (APIs) and finished drug formulations. These intermediates are critical compounds formed during the production stages, leading

To assess health inequalities research involving the pharmaceutical industry and to highlight key themes and potential research gaps. Briefly, a literature search of article titles on the Embase and MEDLINE databases was performed to identify relevant peer-reviewed literature published between 2000 and 2023. A review of gray literature sources and pharmaceutical company global websites was performed in parallel. Peer-reviewed literature and gray literature were excluded during pre-screening based on pre-defined eligibility criteria. Peer-reviewed publications that met the eligibility criteria underwent double-blind title and abstract screening to determine relevance to health inequalities research; gray literature was screened by one reviewer. All publications included after title and abstract screening underwent full-text review. The peer-reviewed literature search yielded 1,377 initial results, of which 18 publications were included for data extraction; the gray literature search yielded 10 articles. Peer-reviewed publications involving the pharmaceutical industry increased over the past 5 years. North America was included as the region of research focus or study population in 61.1% (11/18) of the peer-reviewed publications. Health inequalities across race/ethnicity (66.7% [12/18]), sex/gender (44.4% [8/18]) and socioeconomic status (27.8% [5/18]) featured in the identified publications. Across the medicines and vaccines development and launch process, 71.4% (5/7) of the publications focused on increasing clinical trial participant diversity. The pharmaceutical industry has contributed to the discussion on health inequalities, particularly over the past 5 years. However, industry can better take the wider determinants of health into consideration when designing strategies of evidence generation across the medicines development pathway. Health inequalities describe the often unfair differences in the health of different groups of people. This could mean differences in people’s health or in factors affecting people’s health. There are different aspects that can lead to health inequalities, such as race and ethnicity, sex and gender, and income. Researching health inequalities may help to identify groups of people with an unmet need and help to make sure healthcare resources are spread fairly in the population. We searched English-language articles and information published since the year 2000 to find out about the scientific research and activities that the pharmaceutical industry is involved in to address health inequalities. We found 28 articles that met our criteria, which we reviewed in full. We found that there has been an increase in health inequalities research involving the pharmaceutical industry since 2018. Most of the research we identified included North America as the global region of research focus or study population. Race and ethnicity were the most frequently researched aspects of health inequalities. Overall, we found that pharmaceutical companies are increasing their involvement in research and activities to help to reduce health inequalities. There is still a lot of work to do in health inequalities to ensure that people with an unmet need are not being overlooked and that healthcare resources are available to people who need them. This article includes a graphical plain language summary in the supplement.

The objective of our scoping review is to identify all scientific papers that used internal industry documents in the pharmaceutical sector and analyze what and how the scientific literature learned about corporate influence in the pharmaceutical sector through these internal documents. The scoping review allows to explore the systematic strategies used by drug companies to influence scientific knowledge, professional practices, public policy, and public opinion for their corporate interests. When it comes to public health and healthcare research, internal company documents often serve as unique sources for evidence of corporate activities in pursuit of strategic goals. We identified 37 papers in the final results. All articles obtained most of their internal document data through legal proceedings. All 37 articles unveil dynamic ghost-management strategies that pharmaceutical corporations employ to safeguard their corporate interest. The strategies identified relate to scientific capture (n=28), professional capture (n=16), regulatory capture (n=6), media capture (n=3), market capture (n=4), technological capture (n=2), civil society capture (n=4) and others (n=2).

This statistic shows the number of total approvals from the top 10 pharmaceutical companies in 2017. During this year, Medtronic had a total of 791 approvals. A PMA (premarket approval) is a process undertaken by the FDA in the United States, to review and evaluate the safety and effectiveness of Class III medical devices. A traditional PMA application requires large volumes of information to be submitted such as device description and intended use, clinical studies, and labeling. The applicant is often the individual who owns the rights or has authorized access to the information required for submission.

The Highly Potent Active Pharmaceutical Ingredients (HPAPIs) market has emerged as a critical component of the pharmaceutical industry, characterized by the production and commercialization of highly potent compounds that are essential for specialized therapies, particularly in oncology and other targeted treatments

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Medical, Legal, And Regulatory Review Software Market Size 2025-2029

The medical, legal, and regulatory (MLR) review software market size is forecast to increase by USD 9.7 billion, at a CAGR of 11.4% between 2024 and 2029.

The MLR review software market is experiencing significant growth, driven primarily by the expanding life sciences industry. This sector's increasing complexity and regulatory requirements necessitate advanced software solutions for managing medical, legal, and regulatory reviews. Another key trend influencing market expansion is the rising adoption of cloud-based MLR review software. This shift towards cloud solutions offers numerous benefits, including cost savings, increased flexibility, and enhanced collaboration capabilities. However, despite these opportunities, challenges persist in the market. One significant obstacle is the difficulty for organizations to adhere to budget constraints when implementing MLR review software. Machine learning and artificial intelligence technologies are being integrated to enhance data visualization, risk management, and safety reporting capabilities. Regulatory submissions, version control, and document management are streamlined through these solutions.
Additionally, the complexity of MLR review processes and the need for customization can add to the overall cost. To capitalize on market opportunities and effectively navigate these challenges, companies must carefully evaluate their budgets and consider the long-term cost savings and operational efficiencies that MLR review software can provide. Predictive analytics and big data are increasingly integrated into MLR software to improve incident management and risk mitigation, while data backup and data backup strategies are essential for business continuity.

What will be the Size of the Medical, Legal, And Regulatory (MLR) Review Software Market during the forecast period?

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The market is witnessing significant activity and trends, driven by the need for enhanced quality assurance and regulatory compliance in the healthcare industry. Regulatory landscape shifts, such as global regulatory harmonization, necessitate the adoption of advanced MLR solutions to manage electronic submissions, clinical trial management, audit management, document archiving, change management, workflow optimization, collaboration tools, real-world data (RWD), and knowledge management. Regulatory intelligence is a critical component of these solutions, ensuring data retention, data standardization, and data governance to mitigate risks and maintain patient safety.
The market is also witnessing the emergence of collaboration tools and knowledge management systems to streamline workflows and facilitate effective communication between stakeholders. Overall, the MLR review software market is evolving to meet the complex demands of the healthcare industry, providing innovative solutions to navigate the regulatory landscape and ensure data integrity and security.

How is this Medical, Legal, And Regulatory (MLR) Review Software Industry segmented?

The medical, legal, and regulatory (MLR) review software industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in 'USD million' for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

Deployment

  Cloud-based
  On-premises


Business Segment

  Large enterprises
  SMEs


End-user

  Pharmaceuticals
  Biotechnology
  Healthcare
  Food and beverage


Geography

  North America

    US
    Canada


  Europe

    France
    Germany
    UK


  APAC

    Australia
    China
    India
    Japan
    South Korea


  Rest of World (ROW)

By Deployment Insights

The cloud-based segment is estimated to witness significant growth during the forecast period. In the dynamic landscape of the MLR review software market, cloud-based solutions are gaining prominence due to their ability to address the evolving needs of organizations. These solutions offer accessibility, scalability, and seamless integration, enabling efficient management of compliance and regulatory review processes. The focus on optimizing workflows through automation and data-driven insights is driving the adoption of cloud-based platforms. Real-time collaboration across departments and geographic locations enhances operational efficiency, while advanced security measures ensure data protection. As industries navigate complex regulatory environments, cloud solutions play a crucial role in ensuring adherence to evolving standards.

Regulatory affairs software, API management, and audit trail features ensure compliance with ICH guidelines, FDA regulations, GXP compliance, and ISO standards. Data privacy and electronic signatures are prioritized to maintain data integrity. Cloud-based MLR review software is a game-chang

Clinical Trial Data Visualization Market Outlook

The global clinical trial data visualization market size is projected to grow from USD 0.75 billion in 2023 to USD 2.62 billion by 2032, reflecting a compound annual growth rate (CAGR) of 15.2% during the forecast period. This growth is driven by the increasing complexity of clinical trials, the need for enhanced data transparency, and the rising adoption of digital tools in the healthcare sector.

One of the key drivers for the growth of the clinical trial data visualization market is the escalating complexity and volume of data generated during clinical trials. The pharmaceutical and biotechnology sectors are witnessing a surge in clinical trials, which demand sophisticated data management and visualization tools to make sense of the vast amounts of data collected. These tools enable researchers to identify patterns, trends, and outliers more efficiently, thereby accelerating the decision-making process and improving clinical trial outcomes.

Another significant factor contributing to market growth is the increasing emphasis on data transparency and regulatory compliance. Regulatory bodies, such as the FDA and EMA, are mandating greater transparency in clinical trial data to ensure patient safety and data integrity. Data visualization tools facilitate the clear presentation of complex data, making it easier for regulatory bodies and stakeholders to review and approve clinical trial processes. This ensures that clinical trials are conducted in a more transparent and compliant manner, thus driving the adoption of these tools.

The advent of advanced technologies, such as artificial intelligence (AI) and machine learning (ML), is also playing a crucial role in the growth of the clinical trial data visualization market. These technologies are being increasingly integrated into data visualization tools to enhance their capabilities. AI and ML algorithms can analyze large datasets quickly and provide insights that were previously unattainable. This not only improves the efficiency of clinical trials but also enhances the accuracy and reliability of the data being presented.

As the clinical trial data visualization market continues to expand, the importance of Clinical Trial Data Security becomes increasingly paramount. With the vast amounts of data generated during trials, ensuring the confidentiality, integrity, and availability of this data is critical. Organizations must implement robust security measures to protect sensitive information from unauthorized access and breaches. This involves not only securing the data itself but also safeguarding the systems and networks that store and process this information. As regulatory bodies tighten their data protection requirements, companies are investing in advanced security technologies and practices to comply with these standards and maintain trust with stakeholders. The focus on Clinical Trial Data Security is not just about compliance; it is about ensuring the reliability and credibility of clinical trial outcomes, which ultimately impacts patient safety and the development of new therapies.

Regionally, North America is expected to dominate the clinical trial data visualization market due to the presence of a large number of pharmaceutical and biotechnology companies, a well-established healthcare infrastructure, and a strong focus on research and development. Europe is also expected to witness significant growth, driven by the increasing adoption of digital technologies in clinical trials and supportive regulatory frameworks. The Asia Pacific region is poised to grow at the fastest rate, fueled by the expanding pharmaceutical industry, growing investments in healthcare technology, and an increasing number of clinical trials being conducted in countries like China and India.

Component Analysis

The clinical trial data visualization market is segmented into software and services based on components. The software segment is expected to hold the largest market share during the forecast period. This can be attributed to the increasing demand for advanced software solutions that offer real-time data analysis and visualization capabilities. These software tools are designed to handle large volumes of data and provide intuitive visual representations that facilitate better understanding and decision-making.

Furthermore, the integration of AI and ML technologies into data visualization software is enhancing their capabilities, makin

This statistic displays the percentage of patients who believe that they are proactive in reviewing information on certain health issues in 2014. In that year, 75 percent of people taking long-term medication described themselves as proactive in reviewing information on chronic conditions. Many believe its important to have complementary services to pharmaceutical products.

Patients describing themselves as proactive

About 80 percent of patients currently taking medication often refer to themselves as proactive in reviewing information about medication, while only 65 percent say they actively review information on certain illnesses or ailments. Many pharmaceutical companies provide certain services for their patients such as product information or nurse support via the phone, along with their medications. Patients that receive these types of services often appreciate their value and often feel that these services could be received via digital or online channels.

Product information on medication is one of the most commonly received services, with 48 percent of users obtaining this information. A rewards program is desired by about 63 percent of patients in the United States but only 10 percent receive this option. Financial assistance is also rated as one of the most important services, with about 64 percent of patients listing it as part of their top five services. Many patients are willing to collaborate with pharmaceutical companies to receive certain services. These firms can use patient services to help launch new products or initiate payer programs for patients and retailers for better service. The healthcare and pharmaceutical industries in the United States spent 1.02 billion U.S. dollars in 2011 on digital advertising and is expected to spend upwards of 2.22 billion U.S. dollars by 2018.

The Contract Pharmaceutical Manufacturing Services in the Softgel Capsule market has emerged as a crucial segment within the pharmaceutical industry, catering to the increasing demand for effective and patient-friendly drug delivery systems. Softgel capsules, known for their ease of swallowing and ability to mask un

Patient Support Programmes (PSPs) are used by the pharmaceutical industry to provide education and support to consumers to overcome the challenges they face managing their condition and treatment. Whilst there is an increasing number of PSPs, limited information is available on whether these programmes contribute to safety signals. PSPs do not have a scientific hypothesis, nor are they governed by a protocol. However, by their nature, PSPs inevitably generate adverse event (AE) reports. The main goal of the research was to gather all Novartis-initiated PSPs for sacubitril/valsartan, followed by research in the company safety database to identify all AE reports emanating from these PSPs. Core data sheets (CDS) were reviewed to assess if these PSPs contributed to any new, regulatory-authority approved, validated signals. Overall, AEs entered into the safety database from PSPs confirmed no contribution to CDS updates. Detailed review of real-world data revealed tablet splitting or taking one higher dose tablet a day instead of twice daily. This research, and subsequent analyses, revealed that PSPs did not impact safety label changes for sacubitril/valsartan. It revealed an important finding concerning drug utilisation i.e. splitting of sacubitril/valsartan tablets to reduce cost. This finding suggests that PSPs may contribute important real-world data on patterns of medication usage. There remains a paucity of literature available on this topic, hence further research is required to assess if it would be worth designing PSPs for collecting data on drug utilisation and (lack of) efficacy. Such information from PSPs could be important for all stakeholders.

In 2024, pharmacy2u.co.uk was the most reviewed pharmacy website in the United Kingdom (UK), with over 453,000 online reviews. Lloydsdirect.co.uk and chemistdirect.co.uk followed, with 298,000 and 96,000 reviews, respectively.

The Cholesterol Absorption Inhibitors market has emerged as a crucial segment within the pharmaceutical industry, particularly due to the escalating prevalence of cardiovascular diseases globally. These medications, which primarily function by limiting the absorption of dietary cholesterol in the intestines, offer a

The Tenofovir, Lamivudine, Atazanavir, and Ritonavir combination drug market is a significant sector within the pharmaceutical industry, primarily aimed at managing and treating HIV. By integrating the potent antiretroviral properties of these four components, this combination therapy not only enhances efficacy but

The Drugs for Traveler's Diarrhea market is an essential segment of the global pharmaceutical industry, primarily addressing the health challenges faced by millions of travelers each year. Characterized by symptoms such as frequent loose stools, cramping, and dehydration, traveler's diarrhea can stem from consuming

The Avatrombopag Maleate Tablets market represents a significant segment within the pharmaceutical industry, catering to patients with conditions such as chronic liver disease who require effective management of thrombocytopenia. As an oral thrombopoietin receptor agonist, Avatrombopag Maleate works by stimulating t

The Pharmaceutical Tablet Hardness Testers market plays a crucial role in the quality control process of the pharmaceutical industry, ensuring that tablets produced meet the required hardness standards for effective delivery and patient safety. These specialized instruments are designed to assess the mechanical stre

The Etofenamate Preparations market has been a significant player in the pharmaceutical industry, particularly in the realm of topical analgesics and anti-inflammatory medications. Known for its effectiveness in alleviating pain and inflammation, Etofenamate is widely used to treat a variety of conditions, including

The Agomelatine Tablets market, an essential segment of the pharmaceutical industry, has gained significant momentum in recent years, driven by the rising prevalence of major depressive disorder (MDD) and the growing recognition of the importance of circadian rhythm in mental health. Agomelatine, a unique antidepres

The Levofloxacin Hydrochloride and Sodium Chloride Injection market plays a crucial role in the pharmaceutical industry, particularly in the treatment of various bacterial infections. Levofloxacin, a broad-spectrum antibiotic belonging to the fluoroquinolone class, is effective against a wide range of gram-negative