LAXAI
From sasCommunity
Company Overview LAXAI is a leading provider of Drug Research and Development services with blended-shore sourcing, and clinical data management services for Life Sciences industry across Americas, Europe, and Asia.
LAXAI’s United States operations serve life sciences organizations by providing wide spectrum of clinical data management and clinical research services.
LAXAI AVANTI Life Sciences Pvt, Ltd. in India provides Integrated Drug R&D outsourcing platform with capabilities ranging from discovery to regulatory submissions backed by data management. LAXAI AVANTI Life Sciences Pvt, Ltd is promoted by the LAXAI and the AVANTI group, one of India’s reputed publicly listed corporations. With a history of leadership and credibility LAXAI is renowned for its high standards of quality, ethics and commitment.
Our presence in USA, Europe and India helps us enhance the productivity and efficiency of BioPharma R&D programs globally to unprecedented levels of cost-effectiveness and quality by bringing together global expertise with the talent and the India advantage.
Integrated R&D Outsourcing Platform (IROP®)
Integrated R&D Outsourcing Platform is a unique offering from LAXAI to enable BioPharma companies to establish, realize and scale their R&D efforts in India with close to zero capital investment. IROP® provides a flexi-scalable platform comprising of resources, facilities and infrastructure to offer customers with the following benefits
No conflict of interest (LAXAI is not -a product company) No IP Concerns No Capital Costs Corporate presence in India Flexible and scalable Availability to diverse talent Minimum risk to realize maximum savings Ability to own under Build, Operate Transfer model No Geopolitical issues to deal with Complete control with local management oversight Regulatory support
Capabilities - Drug R&D LAXAI’s with experienced team offers customers the platform to conduct Drug R&D programs in an accelerated and cost effective manner. We provide a wide range of capabilities in the drug value chain ranging from Target ID/Validation to Clinical research. LAXAI can offer facilities; Infrastructure and Resources to meet specific needs of customer. LAXAI adheres to GxP guidelines.
Target Identification/Validation Lead Generation/Optimization Chemistry Manufacturing & Controls Analytical Research Process Development and Scale up Formulations Development Clinical Supplies Toxicology / Animal Studies BA/BE Phase II - IV
Capabilities - Clinical Data Management and BioStatistics Excellent planning and resources can ensure that your studies yield high quality data within strict timelines and budget requirements. LAXAI Clinical Data Management services adhere to GCDMP principles laid out by SCDM. We have gained extensive experience in understanding the CDISC standards and FDA regulatory submissions.
Analytics Electronic Data Capture Document Management Services Digitization Data Standardization
Global Resource Augmentation With an extensive global network of talented, experienced clinical research and data management professionals, LAXAI is capable of introducing the brightest and most experienced professionals to companies seeking clinical research and data management expertise.
Our strong ties within the life sciences community have enabled us to become a leading supplier of contract professionals for the pharmaceutical, biotech, CRO and related industries.
We specialize in the staffing of all levels of professionals contract basis. Our areas of specialty include:
CRA’s (in-house and regional) and CRC's Project Managers Clinical Managers Data Managers/Data Associates Bio-Statisticians Clinical Programmers Statistical Analysts Regulatory Affairs Associates QA/QC Drug Safety
CDM - Facilities LAXAI provides state-of-the art Clinical Data Management facility located in India. The backbone of the data center is a high speed communication link with Virtual Private Network and Network Management Services. Access Control mechanisms have been incorporated at this Data Center as per 21 CFR 11 guidelines. The access controls include a combination of Physical and Logical access control. The data center has provisions for backup and restoration of data in tapes. The tapes are stored at offshore as per SOPs and BCP/ DR procedures. The infrastructure includes high-availability, secure rack mountable machines which are installed and configured as per IQ/OQ specifications provided by the manufacturer. We have the latest version of software including EDC tools, Document management tools and Digitization solutions. We ensure that COTS software we offer to our customer is in a validated state and supported by the vendor. We have stringent SOPs regarding access control and data management and our Quality Managers ensure that there are no process deviations. We constantly audit our facility to address compliance related issues
Research - Facilities Our laboratory facilities are very well equipped with the latest equipments to handle complex reactions and synthesis efficiently at laboratory and pilot scale. Our experienced pool of team comprises of 20 PhDs (8 postdocs) and over 50 masters and can handle complex reactions and synthesis efficiently. We have wet lab space scalable to 140,000 sq ft to cater clients with different engagement models. We have SOP’s driven facilities and our Labs are GLP/GMP compliant.
Engagement Models FTE (FULL TIME EQUIVALENT) MODEL: LAXAI outsourcing platform offers a comprehensive Full Time Equivalent (FTE) engagement model tailored to meet each client’s need for rapid screening and testing of compounds or Data Management Services.
CAPTIVE MODEL: In addition to offering a IROP® Platform, LAXAI offers Captive engagement model that can turbo-charge R&D engines for biopharmaceutical companies. Many large and small pharmaceutical and biotech companies have discovered that there is a need to reduce cost, ease backlogs and capacity shortages, particularly in labor-intensive phases of early-stage chemistry and of data management during clinical study in To address this need, LAXAI provides clients with dedicated facilities, resources and infrastructure in such a way that the client feels as it would be if they were using professionals in one of their own laboratories or data management centers.
BUILD, OPERATE AND TRANSFER (BOT) MODEL: Global Biopharmaceutical companies have come to appreciate the advantages of conducting R&D in India and that the option has been increasingly a “must to do” to have R&D operations in India. However there are several challenges that companies face like setting up infrastructure, building teams, dealing with geo-political and regulatory issues and of-course the huge capital costs involved. LAXAI enables Biopharmaceutical companies to rapidly start their R&D operation in India, realize the cost savings make them sustainable and then transfer then as their own subsidiary.
Contact Information
LAXAI Vamsi Maddipatla No.9, ICICI Knowledge Park, Genome Valley, Turkapally, Shamirpet, Hyderabad, Andhra Pradesh 500078 INDIA Phone: 001-7322485500 X-306 (USA) Fax: 001-6096424541 (USA) E-mail: vamsi@laxai.com
