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Info Kinetics

Last updated: 13.02.2014

Address: Info Kinetics Sdn Bhd Suite 126 Kompeks Eureka, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia

Tel: +604-658 9220

Web: http://info-kinetics.com/

Company description

Info Kinetics is set up primarily to serve pharmaceutical companies in planning and conducting pharmacokinetic and clinical trials as well as to provide independent analytical services as part of their drug development program.

Info Kinetics offers services that encompass all stages of drug development, from Phase I to IV clinical trials. This includes bioequivalence and bioavailability studies. The company is capable of rapid trial subject recruitment and provides efficient and effective trial coordination in this region in trials involving all therapeutic areas. Our services are proven to be cost-effective as a result of improved trial coordination. The clinical trials and laboratory services conducted by Info Kinetics adheres to internationally-recognized quality standards.

Info Kinetics is approved as a Research & Development company by the Malaysia Industrial Development Authority. This status allows organizations using our services and expertise to enjoy a double tax exemption on the amount spent in Malaysia.

Products and services

Clinical Solutions:
Phase I / Early phase studies
Phase II-III studies
Clinical trial protocol Design and Review
Research subject Recruitment and Management
Submission to Ethics Committee for ethical approval
Data Management
Pharmacostatistical Analysis / Consultancy
Study Report Writing

Ethics Application:

JPEC or Joint Penang Independent Ethics Committee is a 11-member committee formed under the joint authority of the Penang Medical College and Gleneagles Clinical Research Centre, Penang . JPEC conducts initial and continuing ethical review of clinical trials conducted in Penang Medical College and study sites under the coordination of Info Kinetics. It may also, upon request, review ethical aspects of clinical trials conducted at other private medical institutions or medical clinics. JPEC is unique in that while most ethics committees are institutional i.e. formed by and comprising members from one particular institution, JPEC unites members from the private and public medical centers and institutions in Penang , Malaysia . This enables greater diversity in review expertise as well as prevents duplication of resources. Running an ethics committee that stands up to the internationally accepted Good Clinical Practice standards consumes much resources and a joint committee makes sense for medical centers that infrequently conduct clinical trials. In a joint committee like JPEC, pooling of resources also means members gain more experience in regularly reviewing a wider range of trials of differing complexities.

Laboratory Solutions:

The bioanalytical laboratory of Info Kinetics had been regarded by many as a “Platform for Possibilities”. Info Kinetics’ proud moment is its achievement of OECD GLP accreditation, the first in Asia to do so.

Bench. Bio-samples from pre-clinical studies had been assayed (DMPK, Toxicokinetics). Info Kinetics had also assisted in the drug development & charaterization of herbal compounds.

Bedside. Bio-samples for Bioavailability, Bio-Equivalence & Phase I studies are routinely assayed.

Post-Market. Screening of adulterants in herbals. Urine drugs of abuse screening & confirmation
The laboratory is well equipped with state-of-the-art analytical instruments that provide rapid turn-around time. These equipments include LC-MS-MS, LC-MS, GC-MS and HPLCs which are strictly qualified under vendor IQ/OQ protocols. The laboratory has experience to handle a variety of biological matrices, utilizing various sample clean-up procedures, including solvent and solid-phase extraction (SPE). These procedures are complemented in new or existing assays for the parent drug and / or its metabolites, which are then validated to GLP and ISO/IEC 17025 requirements.
The laboratory provides enhanced drug analytical services that are new in Malaysia and Singapore. These analytical techniques can be applied to analyses of pharmaceutical products, biotechnologically-derived products and biological samples including blood, tissue, urine, saliva and breast milk.

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