We
at Mayfair have a highly experienced and
professional team to help you through the
clinical stages of the drug development
cycle at a good speed and also help you
to control costs throughout the process.
We help our clients to take the right decisions
faster. Our team ensures that the trials
are conducted as per the Good Clinical Practices
required to generate the quality data.
The Independent Ethics
Committee (IEC) following ICH-GCP guidelines
for international acceptance approves all
our protocols, Informed Consent Documents,
Case Record Forms before any study is initiated.
Highly experienced team
with experience in conducting Single centric
and multi-centric trials headed by Dr. Meena
Shah who has rich experience of over 25
years in managing clinical research. She
has successfully led projects in Clinical
evaluations of several companies across
a range of therapeutic areas like: Diabetes,
Epilepsy, Depression, Paediatrics, Asthma,
Orthopaedics, Nephrology, Oncology (Cervical,
Head & Neck Cancer), Infectious and
Tropical diseases which are prevalent in
Africa, South East Asia & Middle East
(e.g. Malaria, Tuberculosis, Leprosy, etc.),
and Dermatology.
We at Mayfair, have
an access to all the Top Medical colleges
approved by Medical Council of India and
also the leading hospitals in the country.
We help you through:
- Developing
the right Protocol and Case Record Form
to give the desired results
- Prepare Investigational
New Drug Application (IND) and Investigator’s
Brochure
- Right SOP
for systems
- The right
site selection with accessibility
- Identify the
right investigators
- Faster Patient
recruitment
- Study monitoring
as per the GCP guidelines
- Data management
and Bio-statistics using Kinetica®
software for Pharmacokinetics, Pharmacodynamics
and In-vitro-in-vivo correlation, and
SAS® software for statistical analysis
of the clinical study results.
- Integrated Clinical,
Bio-analytical and Statistical report.
- On time delivery
of reports with strong emphasis on our
values namely “Transparency, Excellence,
Integrity, Sincerity, Innovativeness,
Punctuality & Accountability”.
- Provide regulatory
support services to
o submit IND to obtain clinical trials
approval
o submit NDA to obtain new drug approvals
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