Clinical Laboratory Science (CLS) writing involves writing a range of documents on the design and performance of laboratory assays, developed for their intended use in clinical testing. Our interactive ...Read more
- Agile document development by timely and on-budget delivery and coordination of writing, review, approval processes and submissions
- Scientific data integrity by adhering to regulatory requirements and GCP and through peer-review, data checks and quality control.
- Expert support in a wide portfolio of therapeutic areas and Medical Devices, for pre-clinical and clinical phases, and epidemiological studies.
- Experience with a broad variety of client templates and style guides, and availability of our own ICH-compliant templates.
Scientific writing plays an important role throughout the development process and after the launch of a product, or throughout the life cycle of a drug, vaccine or medical device.
50% - 75%
market share for medical writing in CROs
experts in scientific writing
Human subject research that assesses the safety and effectiveness of pharmaceutical products is bound to strict ethical and regulatory guidelines. Scientific writing is an integral part of the pharmaceutical industry and plays an important role throughout the development process and after the launch of a product, or throughout the life cycle of a drug, vaccine or medical device. Good medical writing is in high demand and is considered as an asset because of the need to present technical and complex information in a logically structured, clear, impartial and accurate way to a target audience, while following GCP guidelines.
Scientific technical & regulatory writing
- Clinical and regulatory documents (Phase I through phase IV) including study protocols, informed consent forms, ICH GCP-compliant clinical study reports, clinical summaries, investigator brochures (IB), patient safety narratives, patient communications.
- Method of laboratory assay writing, including method qualification reports, method validation reports, method validation protocols, assay performance summaries, briefing documents, response to questions, SOPs and process descriptive documents.
- Regulatory affairs (RA) writing including common technical documents (CTD), paediatric investigation plans (PIPs), and briefing documents.
Stakeholder engagement & market access
- Coordinating content review discussions for matrix organizations and multiple stakeholders.
- Achieving consensus among healthcare professionals in disease management or treatment guidelines.
- Identifying the needs of patients, payers and healthcare professionals.