Coatbe is providing high quality medical writing and clinical trial disclosure services to global pharmaceutical, biotechnology and medical device companies. Medical writing plays crucial role in success of clinical trial, well written medical and regulatory documents not only help to achieve compliance but also saves times.
We are a thriving organization that cares deeply about meeting the goals of every client with due regards to compliance and quality. We are a people and customer focused organization comprising of highly experienced professionals working together to serve our clients.
Our clients include pharmaceutical & biotech companies with products in early and late-stage clinical trials. We build our service teams around our clients' needs with multiple engagement models.
Due to regulatory push under transparency rule, sponsors are required to disclose information regarding clinical trials. Sponsors are required to register their protocols and submit study results to international or national registries.
It is required to register all interventional studies on public registries before study start or within 21 days after study start:
Every clinical trial begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective, design, methodology, statistical considerations and organization of a clinical trial) and ensures the safety of the trial subjects and integrity of the data collected.
A clinical trial or study protocol is essentially a self-contained document or booklet of rules that outline in detail what the trial hopes to accomplish, how the trial will be carried out, how the progress of the treatment program will be assessed, and how the final data will be analysed.
Investigator Brochure summarizes the relevant to non-clinical and clinical studies data about an investigational product (IP). It includes information regarding IP used in previous non-clinical and clinical studies so that the study investigator and others can have the best guidance. In other words, IB is the compilation of the clinical and nonclinical data on the investigational product relevant to the study of the same product in human subjects. Its purpose is to provide clear information like dose, dose regime, route of administration, known adverse events, and possible drug side effects. This information facilitates safety monitoring in the current study.
A process by which a subject voluntarily confirms their willingness to participate in a particular trial after being informed of all aspects of the trial relevant to the subject's decision to participate. Informed consent is documented through
Patient narratives are written for
We support our clients to build visual presentation for research for conferences or for medical affairs.
We support our clients to build visual presentation for research for conferences including development of abstract.
