Europital’s medical writing expertise can provide you with a significant advantage when it comes to communicating the efficacy and safety of study treatments. Throughout the drug, and medical device, development processes everybody involved needs to know whether the products they are researching are safe and effective.
Europital’s medical writers can manage projects efficiently and provide a clear and logical account of studies to assist you in your efforts to communicate these key messages throughout the initial registration and clinical trial cycle and beyond.
Clinical Regulatory Documents (Phase I – IV)
There are many clinical regulatory documents that need to be written throughout the lifecycle of an investigational medicinal product. In each of these, it is necessary to collate the safety and efficacy data that has accrued, analyze them and explain the results clearly. To achieve this, Europital’s experienced medical writers recognise that it is essential to know both the purpose and intended audience of each document.
The audiences for these clinical documents can be regulatory authorities, medical professionals or patients and, as these documents are a presentation of complex scientific and regulatory information, they must be written in a manner that is both logical and easily understood by the people for whom they are intended.
- Clinical Study Protocol
- Clinical Study Report (CSR)
- Patient and Safety Narratives
- Investigator Brochure (IB)
- Clinical Development Plan
- Standard Operating Procedures (SOP)
- Investigational Medicinal Product Dossier (IMPD)
- Common Technical Document (CTD) Modules
- Product Monographs
- Product Labelling
- Summary of Product Characteristics (SmPC)
Medical Device Documents
As medical device regulations and guidelines become more stringent, the need for effective medical writing skills also becomes increasingly important. Europital’s writers have the relevant skills to source the required data concerning R&D, clinical, quality, safety, regulatory, sales, marketing, risk management and manufacturing. Experienced in analyzing complex data and compiling detailed plans, evaluations and reports according to regulatory stipulations, our medical writers are sure to become key members of your authorship team and play a central role in giving your device’s the best chance of success for regulatory compliance.
- Clinical evaluation reports (CERs)
- Post-market surveillance plans
- Post-market surveillance reports
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Summary of safety and clinical performance (SSCP)
Medical and Healthcare Communication Documents
In order to share useful research findings with the global community, the publication of clinical trial results need to be reported in a high quality, comprehensive and timely manner. Europital’s medical writing specialists can help reduce the time from Last Patient Last Visit to primary publication and also to help you communicate your message in a variety of media to a variety of audiences.
Whether aiming to reach scientific and medical professionals, industry peers, or the prospective patient or study participant, Europital can assist in crafting your key messages into the appropriate readability level, desired style, format and design for better engagement with your target audience.
- Primary Publications
- Reviews and book chapters
- Event documentation for Expert Meetings and more
- Conference and congress abstracts and posters
- Slide kits
- SEO-optimized website content and online articles
- Patient information and self-help resources
- Medical education and training media