technical expertise in Statistical Analysis Plan, Reporting and interpreting
analysis results, SAS programming,
and Validation of TFLs (Safety and
Efficacy tables, figures, listings using SAS
or S-Plus/R.) for clinical trials in phases I-IV. We have expertise in most of
therapeutic areas and our specialties are Oncology, Osteoporosis, Diabetes,
Alzheimer's disease and Cardiovascular, Chronic Obstructive Pulmonary Disease (COPD), devices such Elite SPY, surgical
Mesh analysis. We have over 20 years of pharmaceutical
experiences and clinical data manipulation. We had played great role in number
of successful NDA submissions within
pharmaceutical industries. We are familiar with FDA requirements and
knowledgeable of drug approval process, ICH
guidelines, GCP, and
EMEA. We can take your clinical trial
studies to a successful FDA submission using CRT (Case Report Tabulation) for
electronic submissions, implementing SOPs and Working Guidelines.
We have expertise working
with the following statistical and mathematical software packages:
SAS, R, WinBugs, BUGS, East, Adaptive,
Bayesian, JMP, nQuery, MATHLAB, IBM-SPSS, NCSS/PASS.
To discuss more in detail how we can help you to
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your successful FDA submissions, please get in touch with us.
Articles to consider for Clinical Trial
About 10000 clinical trials are undertaken annually in all
areas of medicine, from the treatment of acne to the
prevention of cancer. Correct interpretation of the data
from such trials depends largely on adequate design and on
performing the appropriate statistical analyses. The
statistical aspects of both the design and analysis of
trials are important, with particular emphasis on recently
developed methods of analysis.
1. Guidance for
determining the number of centers in clinical trials
2. Guidelines on Data Safety and
This guideline is to provide
the oversight and necessity of interim monitoring to ensure the safety of the
study participants and the validity and integrity of the trial data. Phase III
clinical trials usually have a Data and Safety monitoring Board (DSMB), with
broad responsibility for monitoring the conduct of the trial.
for the Creation of Analysis Data Files and Documentation of Statistical
Analyses for Submission
Optimal Two-Stage Designs For Phase II Clinical TrialsThe
purpose of this document is to provide guidelines for the creation of analysis
and associated documentation that are submitted to the FDA statistical reviewer
in support of the
primary and important secondary study objectives.
4. Guidance for Contents of the Clinical Study Report
The purpose of this document is to provide guidelines on what information need
to be included in statistical section of the Clinical Study Report (CSR).
5. Guidance for Non-Inferiority Clinical Trials
6. Fundamentals of Biostatistics ( 1. Clinical
Trials (RCT), 2. Validity/Reliability, 3. Assessing Evidence)
Oncology: Optimal Two-Stage Designs For Phase II Clinical Trials
Optimal Two-Stage Designs
Example of this Calculation
Alpha --------------------------------------------> 0.10
Beta ---------------------------------------------> 0.10
Response Probability of Poor Drug (P0) ---> 0.40
Response Probability of Good Drug (P1) ---> 0.60
|Optimal Two Stage Design
|First Stage Sample Size (n1)
|| 28 |
|Upper Limit For 1st Stage Rejection of Drug (r1)
|| 11 |
|Maximum Sample Size (n)
|| 41 |
|Upper Limit for 2nd Stage Rejection of Drug (r)
|| 20 |
|Expected Sample Size If Response Probability = P0
|Probability of Early Termination at P0
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