Biometrics Medical Writing forms a quintessential part of companies providing biometric solutions & services to pharmaceutical, biotech and medical device companies. Some of the key Biometric Medical writing services are regulatory and clinical writing, medical writing consultancy, scientific communications, creating survey reports, clinical study reports. Biometrics Statistical Analyses helps companies in supporting the statistical needs right from the clinical development planning phase, clinical trials to the final approval stages. These services facilitate scientists, trainees, trainers, experienced professionals on a broad range of topics like experimental designs, statistical models around biometric applications and experiments, statistical methodology, data monitoring, findings interpretation and also support in regulatory and advisory meeting discussions / orientations.
Biometrics medical writers work closely with statistical and clinical counterparts to write protocols, clinical study report, white papers and publications. An important aspect that the companies providing these services keep in mind is stringent quality checks and proofreading procedures to ensure highest level of quality is maintained and also ensure error free client review. For the projects undertaken, each project is generally assigned with a dedicated team of biometrics medical writers and statisticians who are responsible for managing the writing processes. Typical phases to follow are communicating the plans and approvals from the respective sponsors. It is also ensured that the team has the required documentation and therapeutic expertise to satisfy the client needs. It is also essential that these writers and statisticians must be able to grasp deep level of understanding to allow them to have meaningful discussions with industry experts and subject matter experts.
Biometrics medical writing also plays an important role in documenting the adverse events narratives, consent forms, escalations review which from a pharmaceutical/ biotech or medical equipment companies standpoint is a very critical and sensitive topic to be handled and with the essential expertise that these biomedical medical writers provide, it becomes a job done easy for these clients. Biometrics Statistical Analyses also requires intensive training for the statisticians which includes industry information and policies such as 21 CFR, Good Clinical Practices, ICH standards, programming skills, statistical methodologies etc.
Major challenges in biometrics medical writing are in understanding various countries policies, acknowledging the fact that every country and site are different and adapting to regulatory frameworks designed. The industry demands high quality data management, expert writing services and superior statistical results. In a nutshell the biometrics medical writing services demands right people with the right skills in the right parts of the world.