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Calene Clinical Sciences LLC. Looking to increase or complement your capacity for in-house programs and want to avoid increased overhead? Looking for a Clinical Trial Partner experienced in oncology and medical device studies among other disease areas? Looking for a Clinical Trial Partner based in the Texas Medical Center? 160; . Site management (including Chart abstraction, recruitment, GCP training, IMP mangement and accountability). Audit preparation: FDA inspection preparation.

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Calene Clinical Sciences LLC. Looking to increase or complement your capacity for in-house programs and want to avoid increased overhead? Looking for a Clinical Trial Partner experienced in oncology and medical device studies among other disease areas? Looking for a Clinical Trial Partner based in the Texas Medical Center? 160; . Site management (including Chart abstraction, recruitment, GCP training, IMP mangement and accountability). Audit preparation: FDA inspection preparation.

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3 about us

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7 pageheader

8 page content

9 clinical trial rescue

10 monitoring qa/auditing preparation

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Calene Clinical Sciences LLC. Looking to increase or complement your capacity for in-house programs and want to avoid increased overhead? Looking for a Clinical Trial Partner experienced in oncology and medical device studies among other disease areas? Looking for a Clinical Trial Partner based in the Texas Medical Center? 160; . Site management (including Chart abstraction, recruitment, GCP training, IMP mangement and accountability). Audit preparation: FDA inspection preparation.

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About us

http://www.calene.net/about-us

Calene Clinical Sciences LLC. Calene Clinical Sciences provides customer centric services to assist in your clinical trial needs, so that your company can focus on bringing safe and effective therapeutic products to market and help people lead healthy, productive lives. 160; We hold ourselves to the highest ethical standards of conduct. We are committed to business and scientific integrity through respectful, ethical behavior.

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Blog

http://www.calene.net/blog

Calene Clinical Sciences LLC. From Molecule to Medicine. On 6/21/2014 10:21 PM. A very nice overview of the drug development process. The clinical trial phase is the last but nonetheless time-consuming step before any drug candidate can reach the registration phase with Health Authorities. The clinical trial phase is also where most drug candidates fail to proceed down the pipeline, particularly in the earlier phases. Nature Reviews Drug Discovery. On 6/1/2014 10:25 PM. If the targeted investigational ag...

3

For Investigators

http://www.calene.net/directions

Calene Clinical Sciences LLC. Study Regulatory Binder compilation and review. QA/QC processes prior to monitoring and audit visits. Performed a thorough review of the site regulatory binder to identify gaps in IRB submissions and communication to ensure the overall compliance with regulations and institutional policies. We advised the site investigator to promptly address discovered lapses in submitting to the IRB for continuing review and increase timely communications with the site IRB. Thorough query ...

4

for_sponsors

http://www.calene.net/for_sponsors

Calene Clinical Sciences LLC. Enhance data collection and monitoring processes at trial sites through process analyses and tools deployment. Rescue monitoring visits to meet aggressive timelines. Investigational product accountability and review. Created workflow of communications to increase efficiency in following-up with the site staff and shortened the response time, particularly in regards to time-sensitive information, such as Serious Adverse Event reporting. The site staff was motivated to volunte...

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calene.net

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Calene Clinical Sciences LLC. Looking to increase or complement your capacity for in-house programs and want to avoid increased overhead? Looking for a Clinical Trial Partner experienced in oncology and medical device studies among other disease areas? Looking for a Clinical Trial Partner based in the Texas Medical Center? 160; . Site management (including Chart abstraction, recruitment, GCP training, IMP mangement and accountability). Audit preparation: FDA inspection preparation.

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