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Services @
Lambda:
Our aim is to take care of your entire spectrum of work.
From Pharmacokinetic studies to Bioequivalence studies,
First-in-human studies, Phase II to IV Clinical trials,
Clinical Data Management and Clinical Laboratory Services.
Naturally, we have the experience to cater to all your
needs. Right from our first interaction with you to working
out a detailed project management and execution programme,
we are with you every step of the way.
So far, Lambda has conducted more than 875 BA/BE studies,
257 pilot studies and 618 pivotal studies. We have made 290
submissions to the European Union, 255 submissions to the USFDA, 17 submissions to ANVISA Brazil, 28 to Canada, 16 to
Australia and 12 to ANZ. We have successfully conducted more
than 25 multi-locational phase II & III clinical trials in
different therapeutic segments. More than 80% percent of our
business comes from existing clients, which strongly
suggests the importance given by Lambda to communication,
commitment and trust. It's the power of relationships and we
value it.
So how do you know that Lambda is the right place for
you?
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Here is
a modular system of our services (click individual
services for details):
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Statistical design and analysis of bioavailability
and |
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To organize, write, edit and compile the |
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A strong team of qualified and experienced
statisticians, medical writers with Ph.D’s & MD |
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Central laboratory
services |
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Pathology |
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Investigators support
and supplies |
Why Us?
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CAP/NGSP accredited
Laboratory |
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Elaborate test menu
providing “One-stop-shop” |
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Quick
Turn-Around-Times |
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Project management |
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Protocol development |
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Feasibility Services |
Why Us?
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Project managers with
rich industry experience |
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International network
of experienced monitors |
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Statistical design and analysis of bioavailability
and |
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To organize, write, edit and compile the |
Why Us?
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A strong team of qualified and experienced
statisticians, medical writers with Ph.D’s & MD |
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Data entry services |
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Coding of adverse
events and medications |
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Lab data transfers per
sponsor’s specifications |
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Clinical programming |
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Complete clinical data
management services |
Why Us?
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Ability to support
operations round the clock |
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Equipped with latest
industry leading software tools like Clintrial® 4.5,
SAS 9.1, Oracle SAS® access, I-Review, J- review
etc. deployed in a validated environment |
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Method development/Method validation |
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Method transfer for drugs
in biological matrix |
Why Us?
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Rapid turn-around-time |
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Capability to handle liquid-liquid extractions,
solid phase extractions and derivatization procedures |
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Chiral separations of optical isomers |
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IT Support for
Development |
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Client-specific account management |
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Meticulously planned and systemized caretaking of
your projects |
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Pharmacokinetic support at every stage |
Why Us?
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Effective levels of
communication with sponsor |
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Rapid turn-around-time
for final reports as per ICH E3 backed-up by well
designed infrastructure |
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Latest in technology
and well-proven data management services |
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GCP/GLP Audits (In-process, retrospective & system
audits) |
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Handling regulatory inspections (national &
international) |
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Handling sponsor audits for assessment of Lambda’s
facilities & GCP/GLP compliance |
Why Us?
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Dedicated, qualified & well trained QA auditors |
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Teams with well defined job responsibilities for |
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Organize and support
biomarker testing programs for academia & industry |
Why Us?
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To add value to your
clinical trials |
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To obtain an
indication of efficacy at the earliest possible
opportunity |
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