Our highly-professional biostatistics team has the capacity to process vast amounts of data and can accommodate your needs.
Our professional experts with extensive experience deliver reliable data on the efficacy and safety of pharmaceuticals through precise implementation from statistical planning to final reports. Our ability to respond with flexibility to urgent requests, such as schedule changes and inquiries from regulatory agencies, ensures delivery of a high-quality product in an expeditious manner.
- Point 1.
- Well-prepared project team of highly-skilled professionals
- Point 2.
- Precise statistical plan through total study management to achieve goals
- Point 3.
- Efficient and high-quality analysis from academic experts and advanced SAS programming skills
- Point 4.
- CDISC-standard (SDTM, ADaM) compliant product
Main Services and Details
GCP and PMS
We prepare the following draft documents:
- Statistical analysis plan
- Specifications (e.g. diagram output specifications) and definition documents (e.g. analytical data)
- Analytical programs and validation
- Statistical analysis reports
- Application documents (CTD-capable), assistance in responding to inquiries from regulatory agencies
- Consultations on overall biostatistics
GCP and more
- Protocols preparation (especially biostatistics)
- Code-breaking meeting (e.g. immediate analysis result preparation)
- Pharmacokinetics parameters calculation
- CDISC-standard (SDTM, ADaM) data preparation
- Comprehensive project management of clinical trials
PMS and more
- Data confirmation materials
- Preparation of research paper materials for publication
Message from Biostatistics Staff
I have been adding to my experience in various therapeutic areas of PMS biostatistics from statistical planning in the early stages of surveillance to reexamination applications, and preparing materials for publication of per-reviewed research papers. Speed and quality are always on my mind throughout any operation. I believe furthering my expertise in biostatistics improves both the speed and the quality, but also, indispensable is our ability to respond to issues as a team in addition to a thorough understanding of diseases and drug characteristics. At Asklep, we immediately meet with data managers and medical writers to decide the most effective solution, taking into consideration the entire project,, and promptly offer high-quality responses to issues faced. We have put together a team that provides excellent service with a wide perspective which I believe results in delivering relevant information to medical institutions and patients in a timely manner.
E.U. has 8 years of experience in biostatistics
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