Medical expertise for clinical research

Medical writers accomplish the challenge to cover the width of the medical disciplines in order to develop sophisticated scientific documents or delivering supporting clinical development, registration and marketing of your pharmaceutical drugs. As medical writing is about content and language we adapt the respective scientific documents to your individual needs and targets. When it comes to medical monitoring medical monitoring serves to identify and interpret signals in safety data as early as possible to define the right actions for the patient and the trial.

medical writing

We provide comprehensive knowledge and experience to cover the different demands of medical writing in clinical research. Our medical writers offer in-depth expertise in diverse medical indications. We have profound knowledge in conducting clinical trials across Europe and cover all phases of clinical development. Accordingly, our team has the experience, the skills and the tools for composing scientific document types like study synopses and study protocols, informed consent forms, manuals and operational plans, regulatory submission dossiers, educational or promotional literature, publication articles like journal manuscripts and other documents required in clinical development.

 

Furthermore our Medical Monitoring Services encompass medical surveillance of your trials by experienced clinicians to ensure patient safety and signal detection/interpretation. The Medical Monitoring service also comprises quality control and approval of your trial documents in order to comply with the ethical standards and regulatory requirements for clinical research. Futhermore, our medical experts provide training on specific medical topics.

In addition to our in-house expertise we operate a network of medical consultants who provide professional healthcare knowledge to transform your ideas into clinical trial concepts.

Our Medical Writing & Medical Monitoring services include

Professional advice on study designs

Development

Development of study concepts, trial protocols and observational plans

Development

Composing informed consent forms

Development

Medical surveillance

Execution

Safety narratives

Execution

Preparation of clinical study reports

Closure

Writing of publication manuscripts

Closure

Consulting

Development

Setup

Execution

Closure

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