Life Science.

The Clinical Operations are highly important within a biotech/pharmaceutical/medical device company for any development process. Clinical operations help guide organizations and researchers toward development and exciting medical breakthroughs while maintaining patient safety, data quality and good communication between study sites and sponsors. Holds the overall responsibility of the designing, planning, executing, conducting and monitoring of phases I-IV of the clinical trials ensuring trials run smoothly in accordance with all required protocols.

The Clinical Data Management is a multidisciplinary activity within a biotech/pharmaceutical/medical device company which plays an essential role in the generation of high-quality, reliable, and statistically sound data from clinical trials. Ensures collection, integration and availability of data at appropriate quality and cost leading to drastic reduction in time from drug development to marketing.

The Statistical Analysis System, being the industry standard for data management and analytics of large volumes of data. SAS Clinical / Clinical SAS utilizes SAS technology for clinical trial data analysis in pharmaceutical/biotech and clinical research companies. Focusing on clinical data collection and analysis, gather the required dataset to analyze the data using SAS software.

The Drug Safety/Pharmacovigilance organization within a biotech/pharmaceutical/medical device company holds the overall responsibility of collecting, assessing, preventing, monitoring and reporting of the adverse effects of the sponsor company’s product. They are tasked with protecting patients from harm and quantifying risk relative to benefit of the use of the sponsor company’s product.

The Regulatory Affairs of Clinical Research Organizations involve in new drug/medical device/technology development, with a great importance of sound regulatory strategies in the ever-evolving regulatory environment of clinical trials. All the data accumulated during different study phases in development stages is used to register the drug and thus market the drug. Regulatory affairs (RA) scientists oversee the process of getting a drug through clinical trials and onto the market.

The Validation from the clinical evidence perspective ensures that clinical evidence exists in the medical record for all documented diagnoses/conditions. Clinical validation typically performed in clinical trial facilitate the development of a new medical product. In Clinical trials the accuracy and precision of an endpoint is of critical importance in being able to determine valid results through Validation.