CSIA Services
Medical Writing
We can provide a high quality service with our well experienced medical writers in clinical development
Our medical writers have broad expertise as well as the experience in the field of clinical development. By complying with the relevant guidelines and SOPs, we provide high service quality to fulfill client needs.
Services
Medical Writing (MW) department provides services such as preparation for various documents relating to clinical trial.
- Investigator’s Brochure (IB)
- Clinical Trial Protocol
- Informed Consent Form (draft)
- Clinical Study Report (CSR)
- Study Publication
- Common Technical Document (CTD)
∗In addition to clinical
study, we are also able to provide other various service such as clinical research,
investigator
initiated clinical trial, etc.
Work Flow
- Identification of scope of work with the presence of medical writer, determine the preparation method and work schedule, etc.
- Gathering of documents and information, and preparing of the draft by collaboration with relevant departments
- Inspection and modification of the contents by MW team
- Inspection and when required modification and re–inspection of the contents by quality control
∗Progression report will be provided to the client periodically
- Inspection and proofreading by the client
∗Repeat the modification and inspection process until the documentation is completed
- Final inspection by client
- Submission of deliverables to client
Why CSIA??
- POINT1Medical Writer
- Our medical writers are well–experienced medical writers in regulatory affairs and monitors in clinical development and have extensive expertise in various therapeutic areas. Therefore, we are able to provide the high standard quality service to reach the client’ expectation, minimize the time it will take to deliver the final product to our client.
- POINT2Team Work
- At the beginning of a project, we will organize a medical writing team accordingly to work contents of the project; the tasks will be coordinated with the client, monitors, DM, etc. It is one of the CSIA’s specialties to collaborate with various in–house departments exceeding the boundaries of departments.
- POINT3Total Service
- MW is not just about “writing”.
At CSIA, we are proactively providing various proposals with the perspective of consulting and thinking through the consecutive clinical development process.
By pondering protocol feasibility and with the pharmaceutical applications in perspective, we contribute our clients with more than just the provision of a service, but also to be good working partner to our sponsors.