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Clinical Trials

CLINICAL TRIALS

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We can also prepare or provide guidance on clinical trial documentation, namely the following:  

  • Clinical Study Reports (Phase-I-to-IV)

  • Clinical Study Protocols and Amendments

  • Investigator Brochures (IB) and IB updates

  • Patient Information Leaflets

  • Informed Consent Forms  

  • Literature Searches

  • Reclassification Overviews 

 
We will aim to ensure that all clinical documentation is prepared free of ambiguities or any other issues which could prevent the smooth conduct of a clinical study or management of a study by an Investigator. In the case of Study Protocols, we will endeavour to produce a protocol that has the greatest chance of obtaining approval from the appropriate International Regulatory Board or International Ethics Committee it is submitted to.

Regulatory Documentation

REGULATORY DOCUMENTATION


We can prepare or provide guidance on a wide range of regulatory documentation involved in the drug regulatory process, which includes:

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  • Module-2-and-Module-5-documents

  • MAAs, INDs, NDAs, BLAs-  

  • 120-day updates

  • Nonclinical-Study-Reports and Overviews

  • Response-to- regulatory queries

  • Briefing Documents and Meeting Requests

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All regulatory documentation will be written in accordance with ICH-GCP compliant standards, and as per client specifications. Each document will be written to the highest standard in an accurate and concise manner with the aim to preventing ambiguity and smooth submission. 

PHARMACOVIGILANCE AND SAFETY REPORTING

PHARMACOVIGILANCE AND SAFETY REPORTING

 

Our team of writers have experience in pharmacovigilance and safety reporting and having the following experience within this field:

  • Evaluation of aggregate safety data

  • Authoring of PV reports, PSURs/DSURs, PBRERs, ACO, RMPs and safety narratives

  • Signal detection, evaluation and reporting

  • Experience using ARGUS safety database

  • Involved in process of Signal detections, evaluation and reporting.

CLINICAL TRIAL DISCLOSURE AND DATA TRANSPARENCY

CLINICAL TRIAL DISCLOSURE AND DATA TRANSPARENCY

 

Our team of writers have experience in Clinical Trial Disclosure and Data Transparency and have the following experience within this field:

  • Delivery of practical support to clients to ensure compliance with applicable global and regional registries' regulations/guidelines

  • Protocols registration and results summary preparation/posting on Clinical Trial Registries including ClinicalTrials.gov, EudraCT and national registries

  • Study results preparation and posting for EudraCT

  • Lay summary preparation

  • Preparation of redacted/anonymised documents

  • Active interaction within cross-industry Clinical Trial Transparency Working Groups and initiatives 

  • Plain Language Summaries. 

Market Access

MARKET ACCESS

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  • Abstracts and Posters for International HEOR Conferences

  • HEOR Manuscripts and supporting Global Value Dossiers

  • Input in terms of clinical data, cost and resource use, and epidemiology related data

Scientiic Documentation

SCIENTIFIC DOCUMENTATION 
 

Our team of writers can also prepare or provide guidance on any type of scientific documentation. We offer a wide range of services under this category:

  • Dissertation, essay and assignment proof-reading (blogs, articles, website content, slide share, study materials, teaching manuals, book chapters, research articles, and SEO-oriented articles)

  • Scientific component authoring

  • Monographs, newsletters

  • Publication Planning

  • Publications for scientific journals

  • KOL Mapping

  • Storyboarding e-learning modules

  • Slide decks and Posters for scientific conferences and corporate presentations

  • Manuscripts

  • Literature Searches and literature evaluation and preparation of systematic reviews

 

Abstract Well-versed in the field of academia and medical communications, our team of medical writers can provide you the document you need for whatever audience.   We also provide a professional “proof-reading” service available to anyone from students to companies to agencies or novelists. If spelling or grammar is not your strong points, lean on our expertise. 

Medical Devices

MEDICAL DEVICES 
 

In the emerging world of medical devices our writers experience comprises the following:

  • Performing risk-benefit analysis 

  • Detection of new risks

  • Identifying relevant published literature by performing vigorous database searches

 

Our writers also have experience in the preparation of PMS Plans & Reports, PMCF Plans & Reports and developing SOTA for CERs, and have a sound knowledge of regulatory guidelines related to this such as MEDDEV 2.7/1 Rev 4 and MDR.

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