Medical writing

Medical Writing

In the classical sense, medical writing in clinical trials refers to the preparation of comprehensive documents that are required in clinical research. This is also referred to as regulatory medical writing. The documents include Study Protocols as well as Investigator’s Brochures, IMPDs (Investigational Medicinal Product Dossiers), clinical study reports and publications of the latter. The requirements placed on these documents are very extensive.

In addition to thorough expert knowledge, medical writers require scientific training and journalistic skills as well as detailed knowledge of the regulatory requirements in clinical research. The structure and formatting of the various documents as well as the requirements regarding their content are specified precisely in various regulatory provisions. For example, when writing a clinical study report (outcome report for a clinical trial), the provisions of the ICH E3 Guideline (Structure and Content of Clinical Study Reports, Note for Guidance on Structure and Content of Clinical Study Report) must be taken into account to also meet the requirements for outcome reports laid down in §42b AMG. At the same time, a precise and comprehensible editing of the insights gained from the trial is a prerequisite for successfully communicating the trial results. When writing a study protocol, on the other hand, the requirements laid down in the ICH E6 Guideline must be observed; however, in trials that are also conducted in the US, the requirements of the CFR must be additionally observed.

Our medical writers have a thorough understanding of the ICH, EMA, MEDDEV, EFSA and FDA guidelines and all regulatory requirements, allowing them to prepare correct and comprehensible regulatory documents. We are happy to prepare all documents for you in either English or German, and we give you the option of having these documents translated into the other language by our translation department inexpensively.

Benefit from our many years of experience, our knowledge of the legal provisions and our commitment to having your documents prepared by your desired deadline. We prepare or carry out the following for you:

Clinical study protocols
Clinical study reports
Patient information sheets and informed consent forms (ICF including adaptation)
Investigator’s Brochures
IMPDs
Common Technical Documents (CTD)
Scientific communication materials (marketing and training materials)
Preclinical study reports, expert reports and synopses
Medical and scientific literature reviews
Excerpts, manuscripts and journal articles

Medical Writing

Non-interventional studies (NIS) require documents that partly differ from those needed in phase I-IV clinical trials. The reason for this, and as the name suggests, is that non-interventional studies do not involve interventions by the study team. They are studies in which the treatment is administered according to the usual practice or routine and from which insights for specific goals are to be derived based on this approach. For example, in post-authorisation safety studies (PASS), the main focus is on identifying safety aspects related to the use of an authorised medicinal product. Similarly, in post-authorisation efficacy studies (PAES), the aim is to assess efficacy aspects that supplement the existing knowledge.

Medical writing of a wide range of documents is thus also indispensable in non-interventional studies. Benefit from our many years of experience, our knowledge of the legal provisions and optional possibilities, as well as our commitment to having your documents prepared by your desired deadline. We are happy to prepare the following for you:

Observation plans
Patient information sheets
Manuscripts for publication
Any kinds of articles for publication / public relations

Medical Writing

In the medical technology sector, comprehensive documentation is needed both in preparation for the marketing authorisation or placing on the market of products and for the implementation of clinical trials. Special requirements are placed on medical writing for medical device trials:

On the one hand, every medical device requires extensive technical documentation. In this regard, standards such as ISO 14971, IEC 62304, IEC 60601-1 and ISO 62366 must be considered; recommendations of the notified bodies, such as NB-MED/2.5.1/Rec5, also play a role. On the other hand, quality management is also expected to meet current requirements (i.e. those laid down in the harmonised standard DIN EN ISO 13485:2012 and the Medical Devices Act [MPG]). Furthermore, a clinical evaluation has to be carried out in preparation for the conformity assessment procedure. In addition to this, clinical trials require a CIP (clinical investigation plan or protocol) in which the study schedule is determined.

In addition to thorough expert knowledge, medical writers require scientifically founded training and journalistic skills as well as detailed knowledge of the regulatory requirements of the industry. The structure and formatting of the various documents as well as the requirements regarding content are specified precisely in different regulatory provisions. Complying with the standards and guidelines guarantees that market entry does not fail on account of the regulations.

Our medical writers have a thorough understanding of the ISO standards, MEDDEV, MPG and FDA guidelines and all regulatory requirements, which enables them to create correct and comprehensible regulatory documents. We are happy to prepare all documents for you in either English or German, and we give you the option of having these documents translated into the other language by our translation department inexpensively.

Technical documentation for medical devices (technical file)
Clinical evaluations pursuant to MEDDEV 2.7.1, Rev. 4
Clinical investigation plans (CIP)
Clinical study reports
Patient information sheets and informed consent forms
Medical and scientific literature reviews
Excerpts, manuscripts and journal articles
Scientific communication materials (marketing and training materials)