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All elements of data flow process (e.g., case report form development, validation checks, data listing review, statistics) |
Regulatory reporting of clinical studies requires large numbers of analyses, summaries, and safety and efficacy reports generated with strict adherence to rigorous data management standards. Our staff includes data management and statistical experts who manage and analyze all types of studies from simple to technically complex.
Our goal is to provide sponsors with statistical reports and analyses of absolute integrity good work done right the first time. |
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| Clinical Compliance |
| Clinical compliance services include audit service for Investigator sites as per protocol, SOPs, ICH-GCP and other regulatory requirements |
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ICH-GCP compliance review, |
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IRB audits, |
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On-site investigator audits, |
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Drug accountability reviews, |
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Clinical compliance per protocol. |
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| Clinical Operations |
We offer experienced Clinical Research Associates (CRA's) to monitor and manage all aspects of your clinical trials. Initiation, monitoring and close out visits are run according to sponsors' requirements and reporting methods.
Our CRA's are highly trained and experienced in multiple therapeutic areas. Training includes ICH-GCP guidelines, Standard Operating Procedures (SOP's), technology, scientific & medical topics, and regular updates of relevant industry news.
Our CRA's work closely with sites in order to collect clean data quickly. If more than one CRA works on a project, clear SOP's and good communications ensure consistency in the site's working methods.
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