Clinical trails Outsourcing

2010 Global clinical Services outsourcing

By Rajesh Chowdhry, CEO, Aryan Consulting and Technical Services Inc, Canada

ACE LABORATORIES PVT LIMITED

MANDAWAR
SOHANA- FARIDABAD ROAD
FARIDABAD
e MAIL- pmsnetwork@gmail.com
phone- 0091 9999450178

Traditional in-house corporate & clinical trials laboratories are

under pressure:
Whatever the size or configuration of a testing lab and no matter which
technologies and methods they use, they perform a valuable role in assuring
the quality and reliability of a multitude of products. This need for product
testing is met both by in-house laboratories and outsource or independent
labs.
In-House labs offer the company direct involvement with the testing
methods and procedures. A company using an in-house testing procedure is
not dependent on outside sources for meeting its required turnaround
deadlines. Also, knowledge of the product and the required testing
procedures already exists within the company. The outsourced or
independent lab is theoretically free from influence and is able to
provide unbiased results. The objectivity of independent laboratory testing
procedures is monitored by and subject to a variety of outside audits and
evaluations as per ISO 17025 established standards.

The profit motive dictates that independent labs remain competitive with
an emphasis on innovation and efficiency. Technologies are constantly
changing and independent labs are generally better able to keep up with the
latest technological advances. In their thirdparty
position, these labs can also add product credibility via their independent
test results.
The traditional in-house laboratory normally is low on the list for budgetary
funds,impacting the corporate lab's performance. Essential, but expensive
to operate and often under-utilized -- this describes many traditional in-
house laboratories in the energy and petrochemical industries. The global
petrochemical industry alone spends more than $10 billion annually on
laboratory testing. The in-house lab can't deliver state-of-the-art testing,
which very often is what the parent corporation needs. The in-house
laboratory then becomes less useful to the parent corporation. A downward
spiral begins. In-house lab instruments are not replaced nor improved;
expertise and headcount are reduced to the point where the in-house
laboratory cannot meet corporate needs and falls below justifiable
utilization. The long-term future of the traditional in-house laboratory is
an open question.
What's driving the trend for Clinical trials outsourcing:

Structural cost and sustainability issues are driving the outsourcing of

laboratory services. The chemical, petroleum and pharmaceutical industries
are particularly affected by this trend. The in-house laboratory portfolio
of major chemical, petroleum and pharmaceutical corporations is changing.
Where is clinical trials outsourcing occurring:

The United Kingdom, Europe and North America are leading the way, with
Australia, India, China and other locations close behind. Different regions
of the world, and certain countries within those regions, have differing
motivations for considering outsourcing, but they're all considering
outsourcing, Economic and investment reasons are prime reasons, but there
are other motivations to outsource the lab. For example, as former
Soviet Union countries enter global markets, cost savings are not driving lab
outsourcing. Instead they encounter issues related to international
recognition, international quality standards, need for technology and capital
investment. So they're looking to independent organizations to invest
capabilities, expertise and international standards required to become
accepted competitors in their global target markets.

Clinical trials outsourcing benefits:

Cost savings, commercial sustainability and optimal staffing are among the
advantages driving the outsourcing of analytical testing for large companies.
With margins under pressure, every company is looking for optimal
utilization of resources at their disposal. Better assets turnover is the key
under low profit margins in Petroleum and Petrochemical Industry. Thus
outsourcing of laboratory services is becoming the leading trend among
large companies.

How lab outsourcing works:

Corporations are looking for effective ways to break the cycle of high
overhead and under-utilization. A tailored laboratory outsourcing program
can accomplish this goal. Following are the typical steps need to follow

· Performance benchmarking and evaluation by an independent consultant

· Identify the in-house laboratories services into routine samples,

quality control testing and research projects.

· Prepare time chart for expansion and replacement needs of in-house

laboratory

· Schedule phased outsourcing of lab services starting from routine

testings
which are demanding updated methods not available in-house.
Release of resources and deployment in production facilities is the key for
this outsourcing program. Acts Laboratories (P) Ltd brings in the expertise
to perform any one or all of above described functions and can help
companies achieve the goal of optimum utilization of their resources. Our
state of the art communication system guarantees the access to
information, protection of intellectual properties and speed of response.
Clinical trials Laboratory Outsourcing Examples
· Avecia,
· Unilever,
· Citgo,
· Shell,
· bp,
· BASF,
· ExxonMobil,
· Dow Chemical
· Shell Chemical LP,
· DuPont,
· ConocoPhillips
· Ashland Chemical.
· Irving Oil
· Bechtel International
· Toyo Engineering
· Tecknip Italy
· Mistsubishi
· ONGC, India
· Haldia Petrochemicals, India
· Major Steel Plants in India for Environmental Labs

The Future of Clinical Diagnostics-- Ace laboratories pvt Limited

As pharmacogenomics gains prominence as a research and clinical
management tool for clinical trials, ace ;laboratories Clinical Trials maintains
its position as one of the largest and most comprehensive pharmacogenetic-
testing laboratories
The potential use of genotyping to specifically target subjects for clinical
trials is expected to have an increasingly greater impact on enrollment
strategies. As a result, many companies are incorporating pharmacogenomic
testing into their clinical trial protocols.
These assays are intended to evaluate individual variations in whole-genome
or candidate gene single-nucleotide polymorphism (SNP) maps, halotype
markers and alterations in gene expression or inactivation that may be
correlated with pharmacological function and therapeutic response. Quest
Diagnostics offers unsurpassed pharmacogenomic-testing services and
capabilities from both central laboratory facilities and from Ace
Laboratories Private Limited.

pharmacogenomic Capabilities
• Wide range of genetic services performed in-house for optimal quality
and efficiency
• Sequencing analysis from tens of thousands of specimens used to
develop datasets and data resources for product development and
clinical management
• A wide variety of SNP analysis methodologies
• Assays such as CYP2D6, CYP2C19 and CYP2C9
• Custom SNP analysis available for sponsor-specific targets
• Platforms and technologies available for accurate detection of the
spectrum of mutations encountered in either human or microbial
genomes
• Resistance-testing program that screens patients using sponsors'
inclusion and exclusion criteria
• Innovative R&D capabilities that streamline the process of
developing an assay or transferring a technology to our laboratory
• Complete specimen archival and management for both short- and
long-term storage
• Dedicated, purpose-built Molecular Biology Laboratory:

Anatomic Pathology
A full range of Anatomic Pathology subspecialty expertise is available
from Ace laboratories Clinical Trials. You gain access to unsurpassed
in-house capabilities and some of the world's leading pathologists.
• Full range of services
• Routine testing and procedures
 • Specialized testing and procedures
• Multiple specimen options
• Expert staffing
• Anatomic pathology

Science, Research and Innovation

You also gain access to the industry’s widest range of esoteric testing,
and advanced research and development led by our elite medical and
scientific professionals at ace laboratories private limited
Throughout the last four decades, our center for science and
innovation – located in California and Virginia in the United States –
has pioneered many new tests and Clinical Technology
Working together with academia and the biotechnology industry, Ace
laboratories has developed many innovative tools for health risk
assessment, diagnosis and patient management.
Our Academic Associates are highly renowned thought leaders from
elite academic medical centers, who actively contribute to our
research and development program. Our Biotechnology Affairs
program provides continuing access to the discovery power of
biotechnology companies. Moreover, Ace Laboratory has collaborated
on research and development projects with many healthcare industry
leaders and biotech firms.

Cancer Testing
By working with the global leader in cancer diagnostics, you gain access
to a broad range of testing and information services in the detection,
diagnosis, evaluation and treatment of cancer, and related diseases
and medical conditions.
Our extensive diagnostics infrastructure includes over 100 doctors
and doctorate-level scientists providing services in our centers for
excellence and over 10 outpatient pathology laboratories.
Clinical trial elements
The success of any clinical development project depends on a sound
infrastructure and numerous critical key components that we call
“Clinical Trial Elements.” Each element is crucial to ensure your trials
are completed quickly and cost effectively. Partner with us to benefit
from our expertise in each of these specialist areas as part of a full-
service clinical development program, or use us to fulfill a single study
requirement. Whatever you need, we’re an ideal partner to complement
and fit alongside your own in-house capabilities

Ace clinical trial elements:

• Getting started
• Right advice

• tech tools
• Managing sites

• Medical know-how

• Protecting patients

• Medical writing

• Deliver
Clinical Services We out source
• Medical Affairs & Clinical Development Planning
• Interim management
• Clinical Operations
• Clinical Data Management, Biostatistics &
Statistical Programming
• Pharmacovigilance, Drug Safety & Medical
Information
• Regulatory Affairs
• Quality Assurance, GMP, GLP, GCP
• Laboratory
• Clinical Trial Supplie

For business association Please contact

Dr PANKAJ MOHAN SHARMA

ACE LABORATORIES PVT LIMITED
Vpo MANDAWAR
Faridabad -sohana Road
Faridabad , India
e MAIL- pmsnetwork@gmail.com
phone- 0091 9999450178
skype- pankajmohan4