Bio-statistics
Most of our Bio-statistical Services qualify for both in and out-services. We offer various bio-statistical services that complements our data management services. Our wide range of services are offered at all stages of the clinical trial process, from study protocol development through study conduct to formal submissions. Our biostatisticians, affiliates, and programmers are seasoned in their field and have brought many studies of various therapeutic areas to regulating bodies.
Services include:
- Consultation- Offered for study protocol statistical components, data collection methods, data analysis methods, submissions strategy and other bio-statistical reviews.
- Study Protocol Statistical Component Development - Sample size derivation and rationalization/justification, endpoint definitions and hypotheses, and establishment of other scientific soundness methods. We exercise knowledge and expertise in producing the most suitable methods.
- Data Collection Methods - Defining case report forms (CRFs), database elements, and methods of data capture, increasing conformity to the study protocol.
- Data Analysis - perform data analysis using data provided in most data formats (mdb, csv, xls, xml, txt, SAS (6-9), connections to relational databases etc.). Our programmers will execute data analysis plans returning deliverables with our highest accuracy. Their ability to execute data analysis in many operating environments increases our flexibility in dealing with various projects.
- Automated Reporting Methods - we streamline standard reporting to create a more efficient process and system, minimizing the efforts needed for Interim, annual, and other standard reporting requirements. We strive to make the process seamless in crunch time. Our programmers will create solutions that are able to take data from database directly to reports in most cases.
- Our services are also of an auditing and validating nature.
- Auditing - We review statistical processes to ensure adherences to in-house and regulated processes.
- Validation - Our programmers will validate data analysis programs to increase confidence in data analysis routines.
ADB Consulting provides ‘risk assessment consulting’ at the pre-trial to submission stage of clinical trials. Our biostatisticians are ready to work with you providing knowledge and experience. Our bio-statistical programming support are built mainly of SAS Programmers as this has become the industry standard for analytical programming.
Contact us for an estimate or detailing of our services.
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Related Services:
Clinical Study Setup Clinical Study Management Clinical Study Monitoring Clinical Study Auditing Data Management Bio-Statistics Medical Coding Drug Coding Adverse Event Coding Data Analysis Reporting Staffing System Validation
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