Read more about the article What is New Chemical Entity?
What is New Chemical Entity?

What is New Chemical Entity?

  • Post last modified:February 22, 2023
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What is a New Chemical entity? A New Chemical Entity (NCE) is a compound that is not identical to any previously approved drug by regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These compounds have unique chemical structures that have not…

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Read more about the article Behavioral Interview Questions and Sample Answers
Behavioral Interview Questions and Sample Answers

Behavioral Interview Questions and Sample Answers

  • Post last modified:January 27, 2023
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Behavioral interview questions are a type of interview question that asks the candidate to provide specific examples of how they have handled certain situations in the past. These types of questions are designed to help the interviewer understand how the candidate thinks, reacts, and behaves in different situations, and how…

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Read more about the article What is the difference between paper TMF and eTMF?
Differences between paper TMF and eTMF

What is the difference between paper TMF and eTMF?

  • Post last modified:January 27, 2023
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A Traditional Paper Master File (TMF) is a physical collection of documents that are used to store and manage important information related to a clinical trial. These documents are typically stored in binders or folders and are usually kept in a secure location, such as a study site or sponsor's…

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Read more about the article Top Guidance Tips for Clinical Research Freshers
Top Guidance Tips for CLINICAL RESEARCH Freshers

Top Guidance Tips for Clinical Research Freshers

  • Post last modified:July 5, 2022
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Amaan AnsariCompleted B Pharm from North Maharashtra UniversityHaving 3.5+ years of experience in Clinical data managementOn a personal front, I am keen to help and guide individuals in clinical data management and pharmacovigilance.Also on general aspects such as communication skills, inter personal skills, interview tips, Resume Writing, Email Writing etc…

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Read more about the article Centralized Monitoring/Risk-Based Monitoring
Centralized Monitoring/Risk-Based Monitoring

Centralized Monitoring/Risk-Based Monitoring

  • Post last modified:June 4, 2022
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Centralized monitoring is a remote evaluation of the study data, carried out by a team including central monitors, and medical reviewers at a location other than the sites at which the clinical investigation is being conducted. The major difference between CRA monitor and centralized monitor is onsite monitoring and centralized monitoring…

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Read more about the article Clinical Data Management: Basics for Freshers
Clinical Data Management: Basics for Freshers

Clinical Data Management: Basics for Freshers

  • Post last modified:February 18, 2022
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This article is posted from https://www.linkedin.com/pulse/clinical-data-management-basics-freshers-pharmatech-life/ Clinical data management (CDM) is one of the most popular fields in clinical research. Many of the freshers and even experienced want to pursue clinical data management jobs. In the article on how to start a career in clinical data management, we discussed the groundwork…

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Read more about the article Types of Clinical Trial Site Visits – CRA
Clinical trial site visit

Types of Clinical Trial Site Visits – CRA

  • Post last modified:January 13, 2021
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A CRA could be employed directly by the sponsor companies (Pharmaceutical, Biotechnology or any research company) of clinical trials or by Contract Research Organizations (CROs) also referred to as Clinical Research Organizations (As per ICH GCP) that conduct clinical trials on behalf of the sponsor companies. Let's learn about the…

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What is Contract Research Organisation (CRO)? What work CRO’s do?

  • Post last modified:January 25, 2021
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As a fresher or new clinical researcher, we do have a question on our mind that, What is Contract Research Organisation (CRO)? What work CRO's do?. Although the first clinical trial is recorded during the biblical times, the roots of the Contract Research Organization (CRO) can be traced back to…

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