It’s role in Clinical Research

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In regulatory medical writing, various clinical documents are produced during the life cycle of treatment, starting with describing and writing data from clinical trials to preparing regulatory suggestion documents. And once the regulatory authority accepts the therapy, post-approval reports on patients’ treatment are produced. Common Technical Documents (CTD) Clinical Study Reports (CSRs), the Common Technical Document (CTD) are few examples of clinical documents produced by medical writing services using regulatory writing services.

Significance of Regulatory Writing in Clinical Research

Preparation and documentation of high-quality regulatory documents are often under-estimated. A clinical study report (CSR) is the final outcome of many years of hard work by the teams as they need to summarise the conduct and results of a clinical study in a very clear, precise and unbiased manner. A well–written CSR helps in the production of high-quality submission documents. Conversely, poorly written documents can lead to several delays in approvals from the regulatory that can cost the sponsor both time and money.

Experienced and professional regulatory writers can add a lot of value by producing quality clinical study documents. At every step of the clinical research process, starting from protocol development to drug submission process, regulatory writers can act as a pool of knowledge. Skilled regulatory writers are good at meeting global regulatory requirements as they adhere to guidance documents as they fulfill the needs, styles, preferences of study teams or sponsors. The writers try to understand, interpret, and summarize complex statistical and scientific data to provide effective guidance to clinical study teams that usually include experts from other fields such as statistics, clinical, and regulatory.

Functions of the regulatory writer

The regulatory writer’s job is to convert the huge amounts of clinical information that is delivered during clinical preliminaries into reasonable and accurate records for accommodation to the administrative specialists.

The regulatory writer or the clinical author needs to use standard layouts so that there is perfect harmony between phrasing and archives across the segment portions of accommodation.

With experience in relevant novel technologies that have limited approved products, they develop regulatory strategy and rhetorical arguments.

Leading teams or acting as a project manager and increasing the effectiveness and efficiency of the project team that reviews the regulatory documents, ultimately producing better documents

Proven track record of success in medical writing

At Global Pharma Tek, we author clinical and non clinical documents that are required throughout the complete drug development lifecycle and that includes

• Clinical Study Protocols
• Clinical Study Reports
• Patient Narratives and Safety Reports

Our proficiency in therapeutic areas and extensive understanding of FDA, ICH-GCP, EMA guidelines give us an edge in medical writing. We are constantly updating clinical and regulatory guidelines. We keep ourselves equipped so that we can help our clients fasten their clinical process without any hassles.

A complete range of medical writing services are offered by us and we tailor it as per the client needs. Our medical writers can also work conveniently on individual documents and can also create extensive documents as per specifications by the client.

Rigorous quality assurance process

Medical and regulatory documents are very crucial for the success of clinical research. The documents need to be compliant with all the regulatory requirements. Our rigorous quality check processes at every step ensure that all regulatory specifications are met to deliver quality material for our clients.

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