» Medical Writing is an integral part of clinical research. Our Medical Writers work closely and inlinie with your biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards.
» Our Medical Writers have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by us undergo thorough scientific, statistical, editorial and quality control review.
» GCP Monitor’s medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy.
According to ICH GCP E6(R1), Protocol is "A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents."
» According to ICH GCP E6(R1), Informed consent is "A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form."
» According to ICH GCP E6(R1), Case Report Form (CRF) is "A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. "
» According to ICH GCP E6(R1), Clinical Trial/Study Report is "A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report."
» According to ICH GCP E6(R1), Investigator Brochures is "A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects."