Outsourcing-pharma.com presents a round-up of developments in the contract research sector with news from Max Neeman, ACM and Verum.de.
First up is Indian CRO Max Neeman, which has expanded its presence in Bangladesh, Sri Lanka and Malaysia to increase access to patients.
In Bangladesh the contract research organisation (CRO) has established contacts with the leading investigators and physicians who will work with its regulatory team on site selection, patient qualification, monitoring and submissions. It has also established similar relationships in Sri Lanka and Malaysia.
COO Renu Razdan said: "Additional Asia-Pac presence allows us an access to these geographies and hence the subjects." He also stressed the benefit of local regulatory knowledge for sponsors.
"All countries have Regulatory requirements; India is no different and while it may take some additional time to approval, Max Neeman will be ready to start and Sponsors can rest assure that faster recruitment will make up the time."
Drug induced liver damage
ACM Global Central Labs has added drug-induced organ toxicity (DIOT) monitoring to its contract services offering.
The new service will focus on real-time detection and monitoring of elevated liver toxicity biomarkers, which signal potential drug-induced liver injury (DILI) and have been a focus of the US Food and Drug Administration (FDA) since 2009 .
ACM said clients will be provided with trending reports that are generated when the critical level of each analyte is detected in a patient. Once in the surveillance system patients will be monitored by ACM Global scientists until the end of the study.
Kathleen Murray, executive director, Scientific Affairs at ACM, said: “As part of our DIOT surveillance services, our scientific and data management experts work in close collaboration with our clients to provide the optimal monitoring service for their studies.”
Verum.de joins Biocom
And finally German CRO Verum.de - which specialises in running trials in Central and Eastern (CEE) counties - has joined Californian life sciences organisation Biocom.
Verum said it joined Biocom to expand awareness of its services as well as its ability to run clinical trial services with Western standards in both CEE and former Soviet bloc countries.
The move comes just a few months after the CRO opened its first office in the US , which was acknowledged by Biocom senior VP Jennifer Landress.
"Verum's decision to open a U.S. office in Southern California affirms our reputation as one of the top life science communities in the world, and we're looking forward to working with them to continue developing initiatives and services that improve people's lives."