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Medical Writing

Sciencefiles helps in the preparation of key documents for the registration of bioequivalence and therapeutic equivalence studies, early phases of clinical trials, along with registration and post-marketing studies. You can also contact Sciencefiles for help in creation of scientific and medical marketing manuscripts, research or review articles, and some materials for healthcare providers and patients.

We create, edit, and review all phase I through IV medical trials for documentation, preclinical and/or clinical reviews of medicinal products (including Common Technical Document [CTD]), and risk management plans for pharmacovigilance. All the paperwork is completed in accordance with national regulatory authorities comments and Good Clinical Practice (GCP) guidelines. All our authors are highly educated specialists in fields of medicine or pharmaceuticals and have a science degree and GCP certification. For the preparation of manuscripts, we use Standard Operating Procedures (SOPs), which are based on actual regulatory documents.

Key documents:

  • Clinical study protocol
  • Informed consent form and leaflet
  • Clinical Investigators Brochure (with optional development of nonclinical and/or clinical study reviews)
  • Literature review and summary of nonclinical and clinical studies in the Common Technical Document format (CTD).
Clinical study protocol

The clinical study protocol documents the main study goals, the format of the organization, the clinical study methodology, statistical methods, and measures to ensure the safety of drug study participants. Moreover, the clinical study protocol usually includes previous data and the study background. This information can also appear in other documents the protocol refers to.

Protocol development includes two steps: synopsis creation and development into the full protocol. We start creation of the protocol synopsis with the approval of the customer (contract deadline doesnt include an arrangement time).

Phases of protocol development:
  • Literature search and review of clinical trials on a drug or its analogues
  • Optimal primary end point selection
  • Sample size calculation, considering the drop out rate;
  • Creation of synopsis with the list of procedures
  • Unlimited discussion of the synopsis and its finalization according to customer requirements
  • Protocol development from the synopsis
  • Medical, regulatory, and common quality control of the final document and its structure review
  • Proofreading before the document is finalized
  • Starting, interim, and final teleconference during protocol development (as needed)
  • Unlimited storage period for the final document
Clinical Investigators Brochure

Clinical Investigators Brochure is the summary of the preclinical and clinical study results of the drug. This document provides all information necessary to help researchers in understanding the entire protocol and in following its important statements (such as dosage, dosing frequency/rate, administration route, etc.), along with safety monitoring information.
Several types of Brochures are available, depending on the source, quality, and completeness of data:
  1. Brochure development using only customer-provided materials
  2. Literature search of preclinical and clinical studies and further brochure development
Literature search is limited to open access scientific articles and some commercial resources. We discuss the possibility of the customer obtaining all the basic literature resources before the start of a search. We can only use certain restricted articles containing confidential data or restrictions for commercial use after obtaining permission from the holder.

Steps of Brochure development based on resources available:
  • Creation of Investigators Brochure based on customer-provided literature resources
  • Open access search for additional information for some Brochure sections
  • Document and its finalization according to customer requirements
  • Regulatory and common quality control of the final document and its structure review
  • Proofreading before the document is finalized
  • Initial, interim, and final teleconference during protocol development (as needed)
  • Unlimited storage period for housing of the final document
Steps of Brochure development based on additional information obtained by Sciencefiles specialists:
  • Preparation of review with use of approximately fifty literature sources (final document about 20 pages of text in Russian)
  • Unlimited discussion of the document and its finalization according to customer requirements (if literature search is a separate order)
  • Proofreading before document finalization (if literature search is a separate order)
Informed consent form and leaflet

Informed consent form and leaflet a document containing the clinical study information in an intelligible form for potential participants along with the informed consent form. The document can be prepared based on the protocol provided by the customer or designed by Sciencefiles. Document development starts upon Sponsors approval of the final version of the protocol. Steps for Informed Consent form and leaflet development:
  • Clinical study protocol review concerning information essential to creating the Informed Consent form in accordance with GCP requirements
  • Patient information leaflet and Informed Consent development
  • Unlimited discussion of the document and its finalization according to customer requirements
  • Regulatory and common quality control of the final document and text language intelligibility
  • Proofreading before document finalization
  • Initial, interim, and final teleconference during protocol development (as needed)
  • Unlimited storage period for the final document
Literature data review and summary in CTD format

Common technical document (CTD) is a format used to present information to regulatory authorities for medicinal product registration. Since 2016, this format has become obligatory for document submission to the Ministry of Health of the Russian Federation, according to Federal law 61. This format will also be used for document submissions for medicinal product registration in the EEU.

CTD sections may be based on the customers own materials or a literature search (provided by Sciencefiles), depending on the type of medicinal product registration (such as, original/reference or generic, including those that have been on the market for more than 20 years).

If Sciencefiles conducts a literature search, we propose two steps: a primary literature search and reference list presentation with our own conclusion about whether information provided is enough for describing all essential preclinical and clinical studies of the medicinal product and for submission as a CTD. The project can be stopped at this step if sufficient information is not available. The second step begins after the first step results in approval. For the review creation, we can use both previously selected articles and other literature sources that may be found during the work process (for example while compiling the reference list) along with the results of studies conducted by the company sponsor (if applicable).

If customers materials are used based on CTD development for drug registration, the first step is an expert review of information provided for document completeness for the specific registration type of a particular medicinal product. If the information is sufficient for CTD development, the second step would be creation of defined sections.

Risk management plan

Risk management plan (RMP) is a detailed description of all pharmacovigilance actions for drug-related risk detection, evaluation, and prevention or minimization along with an efficacy assessment of these actions. RMP development has been proposed for some medicinal products since 2016 as part of pharmacovigilance program realization plans in accordance with FL-61. RMP is an obligatory document in agreement with the Good pharmacovigilance practice of the EEU.

Whereas primary RMP development is challenging work, the final document usually needs some minimal annual updating. Sciencefiles offers both primary document development, based on customer-provided materials and literature resources and regular RMP updating in accordance with pharmacovigilance practice.

The final document will contain:
  • Epidemiologic study review (based on indications for use according to the drug information leaflet)
  • Literature safety data review for select pharmacological classes of medicinal products
  • Review of the patient population participating in all customer-provided clinical studies
  • Review of the population not investigated in clinical trials
  • Literature review of the drug usage experience (literature search and review)
  • Safety data review of customer-provided studies (both preclinical and clinical)
  • Meta-analysis of the clinical studys safety data
  • Drug prescription/dosing errors risk assessment
  • Search and analysis of any information on adverse events
  • Important identified risks and important potential risk data review
  • Drug overdose risk assessment
  • Review of concomitant disease prevalence in a targeted population taking into account the specter of drug indications, concomitant disease-related risk assessment
  • Risk minimization plan development
  • Review of drug class pharmacological effects
  • Summarized safety information
  • Pharmacovigilance plan development
  • Routine pharmacovigilance arrangement development
  • Efficacy data review (sponsor reports, sometimes several clinical trial meta-analyses)
  • Summarized safety data review in common language
  • Summarized epidemiology and efficacy data review in common language
Research article

Research article An article that contains a description and analysis of customer-provided study results. For this type of article, the customer must present a final study report and the publishing requirements of the interested journal. The expected article size is between 4000 and 6000 words; it may contain up to five tables, figures, and graphs. The article text must be structured in accordance with the specific requirements for research articles of particular types of clinical studies (for example, CONSORT for randomized clinical trials). Upon completion, the article ready for submission for publication is given to the customer. 

Amount of work:

  • Creation of the article text and designing of relevant tables and graphs
  • Terminology verification (medical control)
  • Control of the article for meeting the common requirements
  • Unlimited article discussion and its finalization according to customer requirements
  • Article text and bibliography formatting according to the specific journal requirements
  • Proofreading before the document is finalized
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited time period for storage of the final document
Review article

Review article Scientific articles in the form of a literature review dedicated to any subject of interest. Literature search is limited to open access articles and some commercial resources. We discuss the possibility of the customer providing all the basic literature resources before starting to search for references. The expected article size is 6000 to 12,000 words, and it may contain up to five tables, figures, and graphs. When the article is completed and ready for submission for publication, it is provided to the customer. Amount of work:
  • Creation of a review based on about 30 literature sources
  • Terminology verification (medical control)
  • Review of the article text and structure to ensure that it meets the requirements for scientific publications
  • Unlimited discussion of the article and its finalization, according to customer requirements
  • Article text and bibliography formatting, according to the specific journal requirements
  • Proofreading before the document is finalized
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final document
Materials for healthcare providers

Creation of any materials for healthcare providers (medicinal product summary data, clinical guidelines, visual calculators, or decision-making schemes, tables of risks, etc.), including those for specialized medical sites and customers corporate site. 

Amount of work:

  • Materials development according to the customer order
  • Terminology verification (medical control)
  • Unlimited discussion regarding the document and its finalization, according to customer requirements
  • Proofreading before the document is finalized
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final document
Materials for patients

Development of any materials for patients and the general public (dosage scheduling, diet/behavior recommendations, visual calculators, memos for relatives, etc.), including those for specialized medical sites and customers corporate sites.

Amount of work:

  • Material development according to the customer order
  • Assessment of information intelligibility for non-healthcare providers
  • Unlimited discussion of the document and its finalization, according to customer requirements
  • Proofreading before the document is finalized
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final document