MUMBAI, July 1, 2015 /PRNewswire/ --
Accutest Laboratories recently completed a first-to-file study for the fixed dose combination of Memantine 28 mg ER and Donepezil hydrochloride 10 mg capsule in a record setting time of 5 days. This included volunteer screening, clinical, analytical, QA and report writing activities and submission. The conventional approach of such a study would indicate duration of about 10 days. This positions Accutest Laboratories at the forefront of CROs delivering quality services for challenging projects. Accutest Laboratories is a leading global independent CRO with a track record of more than 2,200 studies and 80+ inspections from all major regulatory bodies worldwide. The company's focus on quality and timely delivery at competitive prices has long established Accutest Laboratories as a successful partner and preferred vendor to the world's largest and fastest growing pharmaceutical companies.
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The successful execution of this study was additionally challenged by the unavailability of the comparator product in the market, simultaneous execution of three studies in parallel, product launch in the US while the studies to be conducted in India. To overcome these challenges Accutest Laboratories implemented proactive measures like preparing multiple protocols with different study designs and sample sizes, obtaining regulatory approvals in advance, prior intimation to the subjects about the possibility of rescheduling/delay of remaining clinical study periods, ready method development, long-term stability and assay transfer completed in advance. These measures performed by an experienced team and best-in-class infrastructural capabilities have contributed to this achievement.
Dr. Satish Sawant, Founder & CEO, said, "Our dedicated team always endeavours to become a preferred partner while encouraging active knowledge sharing with our clients. Meticulous planning in execution and in-depth expertise allows us to design customized solutions as needed and deliver the quality results with quick turn-around-time exceeding our client's expectations."
About Accutest Laboratories:
Its service offerings include:
1. Bioavailability/ Bioequivalence (BA/BE): Accutest Laboratories owns and runs fully equipped, state-of-the-art infrastructure which include 9 clinical pharmacology units with a capacity of up to 346 beds and a diversified database of over 34,000 volunteers. The clinical laboratories are CAP and NABL accredited and bio-analytical laboratories complemented with a pool of 40 highly sensitive and latest generation LC-MS/MS instruments spread across the sites.
Accutest Laboratories has successfully executed more than 2,200 BA/BE studies including most challenging ones from both, a clinical and analytical perspective. Accutest Laboratories is a preferred partner of pharmaceutical companies across the world including USA, Europe, Brazil, South Africa, China, South East Asia, India and more.
2. Clinical Development Services (CDS): Accutest Laboratories also executes clinical trials in Asia for submissions to all major regulatory authorities. In Phase II to IV clinical studies, Accutest Laboratories offers end-to-end services for small molecules, big molecules and medical devices under CDS roof. It also covers Clinical Operations, Clinical Data Management, Pharmacovigilance, and Medical Writing services. These services are offered as standalone or as a bundled package. Experienced project management team with effective planning has successfully completed numerous complex clinical trials across Asian region.
3. Biologics and Biosimilars: Accutest Laboratories delivers comparability solutions for biosimilars, novel biologics and non-biological complex generics. Comprehensive solutions can be provided for complete clinical comparability assessment for biosimilars with respect to both conducting the clinical operations (Phase 1 and Phase 3) as well as bioanalytics for biopharmaceuticals; such as, pharmacokinetics, pharmacodynamics and immunogenicity assessments. Additionally, Accutest Laboratories can also support on certain early stage molecular and functional characterizations such as N - and C - terminal sequence, glycosylation, disulfide linking, ADCC, CDC, Ligand Binding and other Potency assays.
Contact
Pramod Dubey
+91-22-27782049
pramod.dubey@accutestglobal.com
business@accutestglobal.com
www.accutestglobal.com
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