Long Company History
Expertise of 25 years to conduct phase I-IV research for pharma, biotech, phyto, nutritional, medical diagnostic and device sponsors.
Sophisticated Study End Points
We have experience in conducting studies with imaging and biomarker end-points. Our well-equipped central lab has molecular diagnostic capabilities to provide pharmaco-genomic insight. We are equipped to deploy EDC technologies and e-CTD compatible clinical study reports. These help in early availability of CSR.
Enhanced control over study management as a full service CRO – from protocol to study report. We have in-house project management, clinical operations, central lab, clinical data management, biostatistics, medical writing, regulatory consulting, site management services, post-marketing surveillance, peri-approval and rescue studies, amongst others.
Regulatory Credibility and Quality Standards
Quality is built into our service delivery. Our operations are ISO and ICH GCP compliant, research sites are ICH GCP compliant, computerised systems are 21CFR Part 11 compliant and central labs are CAP and ISO certified.
US FDA and WHO have audited phase I studies conducted by us. A number of sponsors have audited our operations resulting in project awards or repeat business. Our studies have been audited by regulators including FDA, and studies conducted by us have been part of regulatory dossiers and have received marketing approval.
High credibility established with European, US and Indian regulators through ongoing audits, namely FDA, EMEA, BfArM, and DCGI, amongst others. |
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Geographical presence and Patient Access
Our direct presence in emerging geographies such as India, South East Asia and Central & Eastern Europe provides access to patients, making our services effective and therefore cost-competitive.
Outstanding enrolment through access to a large patient pool matching disease profiles of key current and future markets over the entire spectrum of indications. For example, we have preferred access to 19 teaching hospitals at Manipal University - Asia's largest academic medical centre with more than 1500 physicians treating 1.5 million patients. With privileged access, we are further able to provide SMO services to improve the research productivity of investigators abroad.
Basis of the Right Talent
Personalised services and flexibility provided with 350 full time professionals, of whom 72 are MDs and PhDs. We have turned the diversity of cultures into synergistic advantages.
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