Rely on the Skills of Our Experienced Medical Writers
Stridon provides medical writing services for both investigator-initiated and industry-sponsored clinical trials. Our objective is simple – to consistently deliver high-quality medical writing projects meticulously, reliably and on time.
The services are underpinned by our in-depth, first-hand experience of clinical trial conduct combined with the long-standing and wide-ranging medical writing experience.
All the work produced by our medical writers undergoes a senior scientific review and a thorough editorial check, ensuring that we deliver high-quality work to our clients at all times.
Our medical writing portfolio includes provision of the following services:
Clinical Study Protocol Development
We develop quality and regulatory compliant Clinical Study Protocols through a close collaboration between our clinical pharmacologists/ medical writers and clients’ clinical trial leader(s). Stridon’s extensive clinical pharmacology and therapeutic experience allow us to craft protocols for the most complex early Phase I trials including First-into-Human, all the way through to multi-site Phase III trials. Where necessary, we will also draw in opinion leaders from a therapeutic area of interest.
Through Stridon’s expert input, we help our clients design the trial in the most efficient, scientifically sound way that ensures patient safety and data reliability.
Clinical Study Reports (CSR) Writing
We pride ourselves on writing high quality Clinical Study Reports for Phase I-III trials. The reports developed by Stridon benefit from our expertise and ample experience both in clinical trial conduct and reporting. They are bolstered by our aspiration for clear, concise and above all scientifically grounded writing. Where required, well-written Study Reports produced by Stridon facilitate a smooth transition to publication, being the basis for future manuscripts, book chapters, and presentations.
Investigator’s Brochure Authoring and Updates
We have many years of regulatory and medical authoring experience together with an in-depth understanding of the required content of an Investigator’s Brochure based on the stage of development and type of drug product. We will ensure that your Investigator’s Brochure provides a concise, objective, and easy to follow summary of all the clinical and nonclinical data relating to your trial drug, in a regulatory acceptable way and to your satisfaction.
Investigational Medicinal Product Dossier (IMPD) Compilation
Many years of experience in dealing with the regulatory aspects of IMPs and clinical trial submissions to competent authorities give Stridon an enviable knowledge base to assist our clients with putting together submission-ready IMPDs. We will compile your IMPD in the most collaborative, flexible and time-efficient way to suit your needs and meet stringent regulatory requirements.
We routinely publish our own research and offer to share some of this experience with our clients by assisting them in publishing the results of their clinical trials and other research.
Get in touch
Contact us now for further information about our medical writing services