Manipal AcuNova, “India’s No 1 Emerging CRO**” is a venture between the Manipal Group and AcuNova. Manipal AcuNova conducts Phase I –IV Clinical Trials and PK/PD Studies to pharma, biotech, device and diagnostic companies. Manipal AcuNova offers Clinical Data Management, Central Lab and Core Imaging services to sponsors and CRO’s. Our facilities located at Bangalore, Mangalore and Manipal in India and in London. Manipal AcuNova has wholly owned subsidiaries in US and UK. The company has delivered cost effective and high quality global studies on schedule to leading biopharma, diagnostic and pharma companies.

** awarded by Proximare Inc- a New Jersey based leading strategic management consulting firm

Key Highlights- Quality Assurance

• First University CRO in India
• The first CRO in India to be awarded the ISO 9001:2000 certification by Underwriters Laboratory (UL) and recommended for the certification for information security (ISO 27001:2005 by UL) and certification on the Central Lab (ISO 15189 certified by NABL -National Accreditation Board for Testing and Calibration Laboratories)
• All research sites conform to ICH GCP Guidelines and personnel have been ICH GCP trained to conform the highest quality and international standards.
• Company wide Six Sigma initiative.
• Successful client audits by Global majors and regulatory agencies.
• Manipal AcuNova’s values of integrity, quality, speedy execution and humane touch guide project implementation.

Vision

Bring new drug therapies and devices to market with innovation and speed. Build an ethical research institution valued by clients, researchers and community.

Team

Leadership at Manipal AcuNova is characterized by outstanding professionalism. Team has over 150 professionals with intellectual acumen and relevant industry experience. Our team has in-depth understanding of the ecosystem we operate in. This enables us to offer insight, objectivity and global quality to our clients.

Innovation and speed

Manipal has invested over five decades of pioneering work in Education and Healthcare and built an international community of skilled professionals with diverse expertise. Manipal AcuNova conducts clinical research in an academic health center setting consisting of University hospitals , with over 1500 physicians. Our access to the teaching hospitals leads to speed in patient recruitment for studies.

Clinical Research

Manipal AcuNova brings in a sharp therapeutic focus to clinical research. The company is equipped with varied resources to conduct Clinical trials ranging from multi centric trials to smaller studies in specialized patient population. With an indepth understanding of the local environment, Manipal AcuNova is able to complete studies quickly without compromising on quality, safety and regulatory issues.

The range of services include:

Regulatory consulting

The regulatory consulting group is experienced in the development of positioning strategies, integrated planning, management, preparation of dossiers and submission to regulatory authorities for smooth transition and conduct of clinical research in India for global regulatory submission.

Investigator /Site selection

Manipal AcuNova explores the investigator and site feasibility for clients thereby ensuring a smooth site selection. The team undertakes the entire process comprising investigators meeting, site monitoring and query resolution.

Patient recruitment/ volunteer selection

Manipal Acunova offers tailored support for recruitment and retention to study site personnel. The patient recruitment programs will speed the recruitment process and shorten the clinical enrollment timeline

Clinical Operations and Project management

Manipal AcuNova’s teams provide integrated planning and implementation from start to end of the study. As partners in research, clients will have access to an experienced project management team that will assist them in various areas of the design and implementation of clinical program.

Clinical Supplies Management

Manipal AcuNova’s services cover the clinical supply process from consultation for clinical labeling to drug destruction in quantities ranging from Phase I to large-scale Phase III/IV studies involving multiple centers. When it comes to driving project completion, Manipal AcuNova provides unsurpassed attention to detail

Manipal AcuNova conducts bioavailability, bioequivalence and various pharmacokinetic studies at all its centers in compliance with international regulatory requirements. The studies are performed on generic drugs, new drug delivery systems and new chemical entities. Manipal AcuNova assures confidentiality, integrity and commitment to schedules to maintain timelines thereby ensuring technical excellence in client engagements.

Manipal AcuNova’s BA/BE center with 84 bedded Human Pharmacological Unit is located at Manipal and Mangalore. In addition there is an integrated Clinical testing and Bio-analytical laboratory. An added 60 bed Human Pharmacological Unit in Vydehi Institute of Medical Sciences, Bangalore will be functional by end of Oct 06. Manipal AcuNova is able to create a quality database of over 2500 volunteers including special population.

Manipal AcuNova Central Reference Lab offers a host of capabilities scaling the facility as a ‘thinking lab’. For patients, the lab offers advanced molecular and esoteric diagnostic services. While for pharma and biotech clients we offer custom tailored studies using molecular and cellular sciences. In addition, laboratory services are provided at all stages of clinical development- from pre-clinical to phase IV trials. Manipal AcuNova ensures a world class system by implementing standards and systems which comply with CAP and NABL standards from sample transport to reporting. This equips the company for any rigorous audit. The lab caters to:

Patient testing service: Samples are tested using state of the art equipment at par with the best in the world. Some of the advanced equipments used are Olympus for Biochemistry analysis and Beckman Coulter analyzer for haematology The lab offers Viral loads for HIV, HBV, HCV using real time PCR, genotyping HCV and HBV using sequencing and nested PCR’s. Other tests offered include immuno-fluorescence assays amongst others

Clinical trial lab service: Manipal AcuNova CRL supports every stage of clinical trials. Lab services are offered to suit the sponsor’s needs. These include test design & statistical validity; regulatory consultation; import of kits, reagents, samples, required for clinical research; investigator briefing; providing central lab service and archival.

Pharma Company research testing service: Drug to drug reaction, efficacy in a genetic type, immunology, HLA matching, biomarkers, are some areas where Manipal AcuNova can provide insight. The company’s biostatisticians provide advice on sample size.

Manipal AcuNova provides comprehensive data management in pre-clinical, bio-equivalence, phase I-IV clinical trials, pharmacovigilance, remote radiology, cardiology and ECG imaging. The company aims towards transforming raw data into consistent, accurate, reliable, meaningful trial output in full compliance with regulatory guidelines. The services offered span every phase of the drug development process.

The team consists of biostatisticians and SAS programmers with sound experience in clinical research. With thorough knowledge Manipal AcuNova can help clients to develop protocols, prepare statistical analysis plans as well as statistical programming for data analysis using both SAS for clinical and PK/PK studies.

Manipal AcuNova ensures comprehensive site management services for clients. While the team will ensure the coordination of study site related activities including centralized budgeting and feasibility activities for the Sponsors therefore ensures quality deliverables on time and within budget. In addition, the team constantly identifies new sites and ensures recommended systems and processes for enhanced efficiency.

India	United States	United Kingdom
Manipal AcuNova Ltd.	AcuNova Life Science Inc.	AcuNova Life Science Ltd, UK
Mobius Towers, SJR i-Park	600 College Road East, #3500	7 March Mount Gate
EPIP, Whitefield	Princeton	Boundary Way, Hemel Hempstead
Bangalore – 560066	NJ 08540	Hertfordshire, UK HP2 7BF
Tel: +91 80 66915700	T: (609) 720 1002	Tel: +44 1442260322
Fax: +91 80 66915719	F: (609) 720 1003	Fax: +44 1442260162
customer@acunovalife.com	client@acunovalife.com	client@acunovalife.com

Contact Information

Manipal AcuNova Ltd
D A Prasanna, Vice Chairman and Managing Director
Mobius Towers, SJR i- Park
EPIP
Whitefield, Bangalore 560 066 India
Phone: 91 80 5691 5701
Fax: 91 80 5691 5719
E-mail:

If you are interested in contacting this provider to receive further information about the services they offer, please fill out the form below to send a direct e-mail message.

Name:
Address:
City:
State:
Zip:
Phone:
Email address:
Message:
	Please note: A number of commercial online services display an error message after you click on Send. Please be assured that your message has been received.