In the context of clinical trials, ISF stands for "Investigator Site File," which is a collection of documents and records that are maintained by the clinical trial site or investigator. The ISF contains all essential documents that demonstrate compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, and study-specific protocols.…
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The drug development process is a long and complex endeavor that involves a wide range of stakeholders, including researchers, scientists, government agencies, and pharmaceutical companies. The process can take many years and is divided into several stages, including discovery, preclinical testing, clinical trials, and regulatory approval. The discovery stage is…
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…
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…
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…
A Trial Master File (TMF) is a collection of essential documents and information that pertain to the conduct of a clinical trial. This includes, but is not limited to, study protocols, informed consent forms, case report forms, investigator resumes, and regulatory approvals. The TMF serves as the primary source of…
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…
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…
What is Regulatory Affairs? Regulatory Affairs in the Pharmaceutical industry is a profession that acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. What are the…
This post is copied from https://www.linkedin.com/posts/amaan-ansari-393562151_interview-interviewtips-technical-activity-6934923283167358976-kDkC?utm_source=linkedin_share&utm_medium=member_desktop_web. Amaan Ansari shared Basic topics that you need to be prepared for Pharmacovigilance Interview. Amaan Ansari is currently working for Parexel as a Clinical Data Analyst. Highly motivated clinical research professional with experience in Clinical Data Management across diverse industries. He is highly active…
• MedDRA Version 25.0 is a complex change version which means changes may made at any level of the MedDRA hierarchy. • A total of 54 new COVID-19 related LLTs/PTs were added including terms related to vaccines which may be applicable in COVID-19. • One new SMQs has been added…
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This article is posted from https://www.linkedin.com/pulse/how-start-career-clinical-data-management-pharmatech-life/ Clinical data management (CDM) is one of the most aspiring fields to pursue in the field of clinical research. I used to get many questions about how to start a career in Clinical data management, and what is the future of CDM and how…
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…
Looking for an opportunity in the Clinical Data Management field? Visit https://discussion.clinicalresearchinfo.com/ and get access to all different Clinical Data Management jobs available in various companies spread across locations. Individuals with good communication skills, team management skills, computer literacy, database skills, etc are worth considering for clinical data manager opportunities. Professionals with a CDM…
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