The Team

 

All statisticians, programmers and medical writers have advanced degrees in related fields.

Dr. William Zhao, President and Chief Statistician, has over 20 years of experience in healthcare industry. He held positions with several major Pharmaceutical companies as Head of Biometrics and Director of Statistics supervising an organization of over 100 members.

Mr. Clem Maurath, head of Safety Statistics, has over 30 years of experience in the pharmaceutical and CRO industry concentrating on safety analysis. His last position in the pharma industry was Director of Global Safety Statistics at Pfizer.

Our Statistics and Programming team leaders both have more than 15 years of experience. All of key programmers have a minimum of 5 years of experience. A team of 5-8 statisticians and programmers can be assembled in 2-4 weeks for clients if needed. Most of our staff has worked in major Pharma or in CROs. Many were key contributors to multiple submissions. All key staff members have at least 3 years of experience in clinical development. 

While we have accumulated a wealth of experience in various types of clinical studies and can provide a full range of services in clinical study and submission, we particularly have built expertise in Statistics and Programming support in study SAP preparation and review, TLG deliverables, DSMB support and CDISC preparation and validation. Our experience in CDISC goes back to 2006 when we completed one of the earliest CDISC NDA submissions for one of our clients. We have worked with both small and large clients in pharmaceutical and other healthcare companies.  

Medical Writing group consists of 8 medical writers. All have numerous experiences in healthcare industry and familiar with ICH guidelines. Our services cover clinical study protocol, clinical study report, integrated summary, NDA submission. We also have a great deal of experiences and capacity in phase 4 studies, publications and presentations.

 

The group has extensive experience and expertise in a wide range of therapeutic areas such as, but is not limited to, the following:   

  • Arthritis
  • Cardiovascular
  • Dermatology

  • CNS

  • Oncology

  • Infectious disease

  • Transplantation

  • Medical devices

  • Diagnostics