Bringing new medicines, vaccines, devices to patients is a time consuming process and companies spend millions of dollars on research and bringing them to market. The research is to ensure safety and efficacy of the drugs. Regulatory submission package development is a challenging skill and FDA, PMDA, EMA approval process can be expedited with Amay’s extensive experience.  The number of clinical trials underway each year has been increasing steadily, worldwide. In the last five years alone, over 75,000 federally and privately supported trials have been registered with the National Institute of Health’s Clinical Trials registry.

Conducting clinical trials  activities results in huge volumes of data. Having real-time clinical metrics and dashboards for insights on patient enrollment, study conduct, close-out and reporting is one of the biggest challenges for bio-pharmaceutical R&D industry. With a broad range of study designs, varying data collection methods and time points, efficient data analysis in clinical development has become more important than ever. The more effectively study data are managed, the faster the data can be extracted and analyzed. The analysis of the data is important to get  valuable insights help increase the efficiency for drug approval.

Regulatory agencies around the world are adopting standards and tools for quicker approval timelines to help make  necessary drugs and vaccines available to patients faster.

Amay built tools to expedite study data management efficiently saving sponsors time and money. Our tools and servers supports your clinical trials by with CDISC SDTM, SAS/R/Python programming , ADaM, Risk Based Monitoring, define.xml, eCRF/aCRF,
CSDRG/ADRG, CSR, TLF, FDA and other regulatory submission process for the pharmaceutical / biotechnology sponsors.