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Considering the diversity of
our country and India's unique regulatory and demographic environment,
Neeman Medical International can help you to achieve your vision with
its mission of providing quality delivery of service to both external
and internal customers.
Neeman Medical International
– with its presence across 22 cities in India and with 5 operational
offices from Delhi, Mumbai, Chennai, Hyderabad and Bangalore – has
access to:
REASONS OF DOING RESCUE TRIALS WITH US:
Fast
Rescue Study Start-up
¨
A new initiative of the Indian regulatory
authority makes it possible to start your study in India within 4-6
weeks. This directive applies to any study that is currently approved
and under way in the United States, the European Union, Japan, or
another major country.
¨
Trained and experienced Regulatory team –
to get regulatory approval within the shortest possible time.
Access to a Large Pool of Patients
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With a population exceeding 1 billion
people and a well developed healthcare infrastructure, India has plenty
of patients in virtually all therapeutic areas and indications.
¨
In particular, India has a high prevalence
of diabetes, cardiovascular disease, hepatitis, cancer, CNS indications,
and infectious diseases.
¨
For most diseases the standard of care is
inline with the Western countries, including the same diagnostic tools
and drugs
¨
Our study team with its presence across
India – provides an ideal platform for rescue study – high patient
enrollment within the shortest timelines
¨
Access to hospital database – helps to
enroll patients for chronic diseases.
¨
More than 90% team members from Neeman are
M.D.s – help to understand the science of clinical trials and helps to
ensure more than 98% patient retention rate.
FDA-Quality Data
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Since 2001, Neeman CR has managed more than
106 Phase I-IV clinical trials for international companies ranging from
small Biotech to large Pharmaceutical industry.
¨
More than 50 of these clinical trials
contributed Indian data to FDA submissions.
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In many of them our research coordinators
provided the recruitment boost required to complete the study.
Unique
Strategy
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Our experience with clinical trials
combined with our unique clinical, data and technology skills allows us
to provide innovative solutions for projects.
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From project onset, we focuses on the final
project goal and identifies potential data, site and protocol issues.
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Address challenges early on and allocate
resources strategically to ensure project completion, on-time and
on-budget.
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If a project requires an initial needs
assessment, our skilled staff will work with the client to identify
issues or problems and develop cost-effective, strategic solutions.
WHAT WE CAN OFFER FOR RESCUE STUDIES:-
1.
List of more than 30 tertiary care
hospitals in different therapeutic areas with:
a.
Investigator details including experience
in Clinical trials
b.
Infrastructure facilities availability at
sites
c.
Details of training and experience of
Investigators and team
d.
Ethics committee timelines
2.
Patient load in different indications
a.
Patient load – both In patient and OPD
b.
Patient data base
c.
Patient load – treatment naïve group
3.
Experience team for each therapeutic areas:
a. We
constitute a dedicated experience team for each rescue study.
b. Project
lead by a project manager with experience in the therapeutic area
c. All
project team members allocated for the study –are with therapeutic area
specific experience.
d. Dedicated
research coordinators allotted to sites from pre-study to study
completion to ensure enrolment and to ensure 100% retention.
e. Definite
project plan in place prior to study initiation
We have experiences in different rescue
projects and have capability to undertake rescue trials in different
therapeutic area
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