What you don’t know may kill your BA / BE compound.

-  Saving money using Indian CROs is great. Depending on your study design,
    the savings can be considerable.

-  But not knowing exactly what is going on is nerve-racking.

-  Receiving poor quality data is unfortunate.

-  Failing an FDA audit is disastrous.

Don’t take a chance.
Abridge is India’s premier BA / BE and clinical end point audit and monitoring service. We specialize in helping USA, European, and Australian sponsors insure accurate and complete reports of their BA / BE and clinical endpoint studies.

Complete. Thorough. Detailed.
Our audits begin with receipt of the IPs at the CRO, and end with the final report. We review all the documents, including the protocol, ICF,CRFs, TMF, pathology laboratory reports, IEC , method development and validation report and all study related documents. We monitor the ICF presenataion, IP dispensing,screening, drug administration, volunteers check in activities, AE/SAEs, blood collection and sample processing, storage, and sample analysis in bioanalytical services. We record every detail, no matter how small. You receive a comprehensive monitoring report within 7 days from the end of the each monitoring visit.

Insurance Policy for an FDA Audit
No one likes an FDA audit, but it happens all the time. Better to be well-prepared than be caught off-guard. With a complete monitoring report from Abridge you’ll be aware of everything that happened in your study – the good, the bad, the ugly. Many items can resolve prior to your submission. In any case, you’ll feel better knowing the facts.

The proof is in the pudding.
See for yourself examples of our reports by downloading these actual (redacted) samples of our work. Check out the documentation we review. Note the attention to detail and the professional writing style. Our reports are clear and concise, and we guarantee your satisfaction.

Simple to engage. Fast to reply. Always at your service.
Our goal is to provide the most accurate and comprehensive audit and monitoring reports possible. We take pride in our responsiveness and we strive to be easy to work with. We know most of the CROs in India, and more importantly, they know us.

Additionally, we have monitored most of the FDA audited CROs in India on behalf of global sponsors. Our CRAs have more than 5 years experience in monitoring BE and clinical endpoint according to ICH-GCP standards. Our CRAs are local residents and native speakers, insuring their understanding of local language and culture.

Simply complete the Study Detail form by clicking here, and we will provide a quotation to you within 72 hours. It’s that simple.