Writing is a talent that many are blessed with but, in the sphere of medical writing anything less than ‘expertise’ does not suffice! Your drug/device/biologic projects and reports are of maximum value only if they are documented concisely and clearly. Whether you are a doctor, a bio-medical researcher, or any other healthcare professional, our expert medical writers are here to provide you with documents that comply with ICH guidelines and health agency requirements.
Up-front messaging, accurate medical nomenclature and terminology, logical construction and flow, and impeccable diction and style tailored to individual requirements – all these undergird our work. The result is a document that is unparalleled in both structure and quality!
Our regulatory and clinical writing expertise includes
- ClinicaL Study Reports in compliance with ICH E3 guidelines
- Case report forms
- Investigator Brochures briefing packages for meetings with health authorities
- Clinical development plans
- Top-line results reports
- Informed consent forms
- Site-specific and country-specific reports
- ICH-compliant summaries for drug, device, and biologic marketing applications
- We also prepare
- Slide presentations
Outsource protocol design to us to ensure success and speed! Excellent protocol design is essential for your clinical trials. We know that clarity is absolutely necessary to ensure safe, consistent, and complete conduct of the study. Our services are set up with this in mind and, in close collaboration with you, we produce a protocol that will ensure a smooth transition of your project to the clinical sites and will help avoid amendments that result when protocols are not clear to begin with.
Our Protocol Design specialists can help with
- Protocol conceptualization, design, and preparation in compliance with ICH GCP guidelines
- Study laboratory manuals to accompany the clinical protocol
- Comprehensive sub-study protocol design and implementation
- Informed consent form design and patient brochures
- Case report form design
- Documents available in English or French
Moreover, our knowledge of clinical pharmacology ensures an easy transition to your first Phase 1 clinical study and to subsequent PK/PD studies.
At Magnentum, we firmly believe in the value of excellent bibliographic searches as one of the foundations of good regulatory submissions and clear argumentation to support filings. Our dedicated team of bibliographical researchers gather relevant information from a multitude of subject areas, putting each individual search through an intensive data-filtration process. The researchers then condense expertly selected information into succinct, reviewer-friendly summaries. Good searches are indeed demanding and time-consuming for all, except for the experts! So let our clinical data team of bibliographical search specialists take over this responsibility while you utilize your time to assure more rapid drug development.
Standard Operating Procedure Development (SOP)
Creating clear and appropriate procedures eradicates the need for interpretation by employees and ensures that the team works in the organized and efficient manner that you need. Our SOP approach is to take into account your clinical operations, clinical monitoring, feasibility, and project management teams. Thus, in close collaboration with you we identify the crucial areas and document clearly and in logical order the necessary procedural steps. Working with good procedures in place helps eliminate inefficiency and the frustration that ensues when employees are working without clearly defined responsibilities and order. A good SOP pays benefits from step one to the final product.
Typical SOP development projects include, but are not limited to:
- GCP training
- Subject screening and recruitment
- Informed consent process and documentation
- Eligibility confirmation
- Source documentation
- Data management
- Protocol deviations
- Reporting of serious adverse events
- Confidentiality of information
- Drug/device storage, accountability, and management
- Regulatory document submission process (initial submissions, amendments and continuing reviews)
- Sponsor, CRO, and internal audits
- FDA audits
Case Report Form Design
Our Clinical Data Managers bring their fifteen years of experience to your project, and design case report forms that help investigational site staff capture data accurately and consistently.
Our CRFs are designed to collect data relevant to the specified protocol. We eliminate inconsistencies that too often result in analysis problems downstream when reports are being prepared. The CRF design process is fully documented for you, including approvals and version control. We know how important it is for the CRF to be available in time for sites to begin enrolment of subjects, so we work to your timelines to ensure the CRFs do not delay study start-up.
Our process includes full training for your team on the protocol, the CRF completion instructions, and data-handling procedures. The training is fully documented so that your training records for the study are always clear and readily accessible.