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Medical Writing Team

Medical Writing Team

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Making Metric Collection Obligatory in Clinical Trial Contracts

Medical Writing Team

Establishing robust metrics at the start of a study, and systems to monitor them in an ongoing manner, should be integral to all work that a Clinical Research Organisation (CRO) performs. There is an expectation from clients that metrics will be used to monitor progress or lack of progress, including deviations from the planned schedule. However, these metrics are sometimes not defined clearly at the outset and often not incorporated into clinical trial contracts. A lot of metrics need to be “balanced” between what is controllable by the CRO and what is controllable by the sponsor. Therefore, the metrics that are incorporated into a contract need to be carefully chosen. Ideally it should be a small and accurate set of performance metrics that will meet the customer’s needs and enforce efficient information flow – it being a breach of contract not to provide and review the metrics.

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Topics: Metric Collection, Clinical Trial Contracts, Clinical Trials, CRO Project, CRO Efficiency, Project Management

Regulatory Writing – An Integral Part of Clinical Research

Medical Writing Team

There are two main areas in medical writing, medical communications and regulatory writing; this blog focuses on the latter area of specialisation, which involves the preparation of clinical study and regulatory submission documentation.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

The Different Phases of Clinical Trials

Medical Writing Team

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans.  These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years.  Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Pre-Clinical Study, Clinical Trial Phases, Phase 3 Studies, Phase 4 Studies, Phase 2 Studies

Compiling the Appendices for a Clinical Study Report

Medical Writing Team

For any clinical regulatory writer, compiling the appendices for a clinical study report (CSR) can feel like a daunting task, but it doesn’t have to be. To make this task easier and less time consuming you need to start thinking about it before you even begin to write the CSR.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

Integrated Summary Tips

Medical Writing Team


Quanticate's Medical Writing Team have summarized tips for the preparation of comprehensive, well-written, and focused integrated summary documentation.

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Topics: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy

The Challenges of Writing Patient / Safety Narratives

Medical Writing Team

There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. This blog describes the scope of narrative projects and outlines the associated challenges and provides some ideas to help you successfully manage narrative projects.

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Topics: Case Report Form (CRF), Adverse Events (AEs), Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Serious Adverse Events (SAEs), Patient Narratives, Safety Narratives, Data Clarification Form (DCF), Quality Control

Remote Monitoring During Clinical Trials, a Risk Based Approach

Medical Writing Team

 

Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies.  With this increase comes the enhanced pressure of effectively monitoring these trials.

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Topics: Regulatory Requirements, Clinical Trials, Good Clinical Practice (GCP), Clinical Data Storage, Case Report Form (CRF), Remote Monitoring, Adverse Events (AEs), Ethics, On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

Challenges and Rewards of Working in a Clinical Research Organization

Medical Writing Team

The business of Clinical Research Organizations (CROs) has been expanding recently due to the slow growth in the pharmaceutical industry. Working for a CRO offers numerous challenges and rewards. The following highlights some of these in greater detail:

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Topics: CRO Selection, Specialist Biometrics CRO, CRO Project, Clinical Research Organization, Request For Proposals

Regulatory Writing: What Does it Entail?

Medical Writing Team

 

Regulatory Medical Writing is often overlooked in the world of Medical Communications.  Regulatory writing, though perhaps less glamorous then the production of conference brochures and magazine articles, is a vital facet of clinical research.

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Topics: Medical Writing, Regulatory Writing, Clinical Documents

Medical Writing Tips For Managing Multiple Priorities

Medical Writing Team

 

 

A Regulatory Medical Writer in a Clinical Research Organization (CRO) is usually involved at the start (writing a study protocol) and/or end (writing a clinical study report(CSR)) of a project. The start and end of a clinical study can be the most stressful time for the team as they work together to meet important deadlines. For the Medical Writer this stress can be further exaggerated by multiple projects converging and study teams demanding more and more of their time with last minute changes. The Medical Writer, as part of a team, will also have to do their fair share of quality control (QC) and/or peer reviewing.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

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