Pepgra Clinical Research Organisation
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Pepgra Healthcare is a leading Contract Research Organization (CRO) assisting pharmaceutical, biotechnology, and medical device manufacturers; we have offices in the US, UK, and India. Our CRO experts support all phases of clinical trials. Clinical research, regulatory affairs, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, therapeutics, Post-Marketing Surveillance (PMS) and more. Pepgra is 9001:2015 certified organization. In addition, Pepgra’s publication division focuses on academic and scientific writing projects. Editing, publication, research, physician writing, and scientific communication—these are our focus areas.
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4. Post- Market safety monitoring
Continue Reading: https://bit.ly/3ryCQC4
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Top 5 tips for managing risks in your clinical studies - Pepgra
Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while preserving patient safety and data reliability in Patient recruitment for clinical trials. In this blog, Pepgra provides five tips for significant risk levels in clinical studies like:
1. Outlining your levels of risks
2. Evaluating and categorizing risk
3. Concentrating on essential areas of risk
4. Observing and controlling risks
5. Estimating the efficiency of risk management
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Role of Biostatistician and Biostatistical Programming in Epidemiological Stu...
Pepgra experts provide regulatory biostatistics and epidemiology statistical programming support to all phases of clinical trial process development and commercialization. Our Epidemiological statistical services is are located globally & trained in current methods and standards to support the successful execution of your projects.
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EMA Guidelines for Clinical Trial Management - Pepgra Healthcare
The document discusses the European Medicines Agency (EMA) guidelines for clinical trial regulations. The EMA aims to authorize pharmaceuticals for European countries based on clinical trial data submitted by companies. While the EMA does not authorize clinical trials itself, it works to ensure trials follow good clinical practice standards for design, conduct, monitoring and reporting. The 2014 Clinical Trial Regulation aimed to streamline the application process for companies and increase transparency. It established a single application portal and harmonized dossier for multi-country trials. The regulation also strengthened patient protections and oversight of trial conduct across European member states.
Side effects of drugs products, medical devices & drugs healthcare data...
Rapid growth in the use of medical devices in health-care sectors has been enabled by technological advancements. Prescription drugs and medical devices can come with dangerous side effects and complications. A side effect will become severe, so it is essential to contact your doctor or pharmacy specialist if you face ant difficulties. In this blog, Pepgra lists the reporting of side effects and its necessities.
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Guidance for Biomarkers into Early Phase Clinical Research Purposes | Healthc...
In many health data analytics companies, Biomarkers are playing increasingly critical roles in the development of new drugs in early-phase trials. This blog is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Some steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial are:
Errors in Measurement, Bigotry, Astounding, Price and Acceptability.
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Recent trends in genomic biomarkers pepgra healthcare
Cardiovascular disease is a significant health concern worldwide despite having many genomics developments providing valuable new candidates for better biomarkers and novel therapeutic targets. The main integration of new technologies promises the discovery and validation of better biomarkers of the presence of cardio disease, its progression, and the response to treatment in this blog. Some of the features are:
1. Analyzing the Gene expression
2. Genome-wide association studies
3. Linkage analysis
4. Wrapping up...
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Recent Trends in Genomic Biomarkers - Pepgra Healthcare
Cardiovascular disease is a significant health concern worldwide despite having many genomics developments providing valuable new candidates for better biomarkers and novel therapeutic targets. The main integration of new technologies promises the discovery and validation of better biomarkers of the presence of cardio disease, its progression, and the response to treatment in this blog. Some of the features are:
1. Analyzing the Gene expression
2. Genome-wide association studies
3. Linkage analysis
4. Wrapping up...
Continue Reading: http://bit.ly/3bqq3Np
Contact us:
UK: +44-1143520021
US/Canada: +1-972-502-9262
India: +91-9884350006
Email id: sales.cro@pepgra.com
Website: www.pepgra.com
Guidelines on Virtuous Pharmacovigilance Practices | Pepgra Healthcare
This document outlines guidelines for virtuous pharmacovigilance practices as presented by Dr. Nancy Agnes of Pepgra Group. It discusses the need to protect patients and public health through pharmacovigilance. The introduction describes pharmacovigilance systems and their responsibility for drug safety authorization. Key principles for guidelines include meeting patient and public needs, providing Good Pharmacovigilance Practice guidelines, and continuous quality improvement. Responsibilities of pharmacovigilance organizations include ensuring qualified staff, adequate resources, and a systematic approach to quality.
Challenges and-opportunities-in-software-driven-medical-sciences
SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run on different operating systems and virtual platforms.
1. The basic programming model of a SaMD is given below.
2. Different softwares are used for medical purposes, and they include the following:
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Clinical trail-designchallenges-in-the-study-design-conduct-and-analysis-of-r...
•The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings.
•Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs.
•The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems.
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Pharmaceutical legislation on notice to applicants and regulatory guidelines ...
1. Notice to Applicants
2. Volume 2
3. Volume 2A – Marketing Authorization
4. Volume 2B: Format and Presentation
5. Volume 2C: Regulatory Guideline
6. Concluison
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Risk managements documents required for the market placement of a medical dev...
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
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A few dedicated search engines for your medical writing
A medical literature search engine is a centralized browser-based platform which will come up with literature related to any of the medical subjects you choose. This is perhaps not a good idea to seek help of every medical resources discussed in this blog, yet using a few of the medical literature search engines will definitely serve the purpose of your constant source of authentic evidence.
To Continue Reading : https://bit.ly/35KkzYL
Clinical Trial Design and Artificial Intelligence | Pepgra.com
Clinical trials take up the last half of the 10 – 15 year, 1.5 – 2.0 billion USD, cycle of development just for introducing a new drug within a market.
1. AI and its Evolution
2. AI in Clinical Trials
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Medical literature monitoring and entering negative reaction reports
The European Medicines Agency introduced a new medical literature monitoring service in September 2015 to avoid duplication of efforts in reporting negative drug reactions. Through this service, the EMA monitors medical literature and enters reports of suspected adverse reactions for certain active substances into EudraVigilance instead of requiring marketing authorization holders to do so. This simplifies the reporting process and improves data quality by reducing duplicate entries that previously resulted from multiple organizations monitoring and reporting on the same substances. The EMA expects this service will enhance the efficiency, quality and resources used for pharmacovigilance activities in Europe.
New medical device regulation: implications for medical device manufacturers
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn More: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
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New Medical Device Regulation Implications For Medical Device Manufacturers
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn more: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
Relevant Medical Databases and Search Engines for Literature Screening
A medical literature search engine is a centralized browser-based platform which will come up with literature related to any of the medical subjects you choose. These search engines are programmed to be connected with the archives of published literature that are stored inside online subject-specific academic databases like the medical literature database.
Learn More: https://www.pepgra.com/relevant-medical-databases-and-search-engines-for-periodic-literature-screening/
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