Clinical R & D
In an environment, where the Medical Device and Life Sciences Industry are faced with compounding challenges of Regulation, Demographic transitions and rising costs to discover and deliver products to market. The industry is constantly evolving to innovate products to improve the life expectancy and address this challenge. i-Quest as your trusted partner would help navigate your organization in managing these complex challenges and help to achieve operational excellence in maximizing value and minimizing costs on your investments.
i-Quest’s expertise is in Delivering Integrated Validated solutions for Life Sciences Industry across Pre and Post Market products. Spanning Business processes and Systems across Clinical and Regulatory Affairs, Quality and Product Management domain.
Clinical Data Management
i-Quest’s expertise in Clinical Study Design and Conduct across Phase 1 through 4, spans systems and processes in enabling efficient data collection toward safety and efficacy analysis in the product development process. The processes span from translating protocol definitions into Case Report Form design to clinical database design and build leveraging CDASH standards in the conduct of clinical trials globally. Additionally the process spanned to integrating lab data to data validation to resolving data queries to reconciling Serious Adverse Event Data to facilitating SAS Data Extract and enabling transformation to CDISC compliance.
i-Quest’s effective implementation of Safety systems would enable you in effective analysis, monitoring of Serious and non-serious adverse events throughout the life-cycle of drugs, biologics and devices to establish a robust product safety profile toward submission for Data Monitoring Committee (DMC) and/or Regulatory bodies. Effective Product Risk Management is enabled through signal detection. Ultimately it’s ensuring a continuous process improvement methodology is adopted within the Product Life-cycle Management framework.
Clinical Trial Management
i-Quest’s expertise is in implementing CTMS with associated integrations enables you to streamline and effectively conduct Site/Account Management towards maximizing insights for your clinical and sales/marketing organizations. Importantly reducing data redundancy across CDMS and Master Data Repository. Additionally enabling effective Subject, Site, Monitoring Operations across budgeting, contract management and associated document management. Importantly i-Quest’s expertise is in enabling Trial insights through out the process of planning, preparation, performance and reporting by leveraging appropriate dash boards.
Computer System Validation
i-Quest’s expertise in Computer System Validation would help guide and ensure your entire validation process emanating from system proposal/requirement through system retirement complies to the intended use. The process spans the retention strategies of document and e-records for regulatory compliance.