Lotus Labs is a Clinical Research Organization with extensive experience in conducting Clinical Trials in healthy volunteers, patient populations and special populations.

1. Innovating Solutions for
Pharma Research & Development
LOTUS
Centre of Excellence for Clinical Research
...to be the most admired clinical research organization from India

3. About Lotus
Lotus Labs Pvt Limited is a Clinical Research Lotus has a dedicated Clinical Development
Organization based in Bangalore, operating team for the conduct of Clinical Trials. The
since February 2001, engaged in the 30 strong team has been involved with
conduct of Bioequivalence, Phase I studies submission studies for major regulatory
and Clinical Trials. bodies. The team offers end-to-end services
for the clients.
Lotus has completed more than 1400 bio
studies to date and several Phase I and The Central Lab, located in Bangalore is CAP
Phase III trials. and NABL accredited. It offers the services for
the examination of hematology, biochemistry,
Lotus operates from 4 sites for its clinical
serology, urine analysis & ECG for screening
operations (3 facilities in Bangalore and 1 in
and safety analysis of healthy volunteers
Chennai) with combined bed strength of 360.
and patients. It has won international
The centralized BIO ANALYTICAL lab located accreditation from CAP and is now serving as
in Bangalore operates in more than 20,000 Central Lab for Global Clinical Trials.
sq. ft. area with State-of-the-art equipments
Lotus has a data base of more than 35,000
like LCMS/MS & HPLC. Lotus has 14
healthy adult volunteers. Lotus employs more
LCMS/MS instruments (13 from AB Sciex
than 450 trained and skilled technical staff.
including 5 API 4000 and API 5500), one
from Waters and 4 HPLC. More than 250 Lotus has set up a central archival facility in
methods have been developed and Bangalore where all study documents are
validated. Lotus has a dedicated team to archived. The facility is spread over an area
develop and validate new methods as of 7350 sq.ft. The facility is well protected
required. for any eventualities against fire and other
natural calamities.
We have a state-of-the-art, fully equipped
Phase I unit in our Clinical Facility which is
located inside the campus of St. John's
National Academy of Health Sciences,
Bangalore for conducting Phase I trials. St.
John's is a 1200 bed hospital covering most
of the important branches of medicine like
Pediatrics, Cardiology, Oncology, Obstetrics
etc. St. Johns Hospital its among the top 10
hospitals in India.

4. Services Offered
Lotus offers an array of services to cater the pharmaceutical and
biotech organizations.
These services involve:
?
Study Design ?
Pharmacokinetics
?Writing
Protocol (Healthy & patient population)
?
Human Bioavailability studies ? services
Statistical
?
Bio equivalence studies ?
Medical writing
? studies
Food effect ?
Special population studies -
Hepatic & Renal impairment etc.
? studies
First in man
?
Biogenerics/ Biosimilars
?Phase III clinical trials
Phase I -
? Services
Regulatory
?
Bioanalysis
(>250 methods validated) ? Services
Pharmacy
?
Data management ? Services
Central Lab

5. Inspections
Lotus has successfully completed more than 40 audits from Indian
& International Regulatory Agencies
?
Drugs Controller General of India ?
AGES, Austria
?
USFDA ?Brazil
ANVISA,
?
EMEA ?
MCC, South Africa
? France
AFSSAPS, ?
MOH, Turkey
?
WHO ?
MCC, Zimbabwe
Lotus has been approved for submission of studies to Sudan and Israel.
Recruitment and Volunteer Database
The Recruitment Team and the Screening Ample explanation and time for signing the
team manage the recruitment of the consent form in the vernacular as well as
volunteers and maintain a database of all English is done to make sure of the volunteers
the volunteers registered and participated in right to information.
the studies at Lotus.
Currently Lotus maintains a
Screening and Enrolment of the volunteers is population of:
done through “biometric” finger print system
? 35,000 normal healthy
More than
that registers the basic information of the
adult active volunteers in the database
volunteer incase he/she had participated in
studies earlier at Lotus Labs. After registration, ?
Non smokers
all the volunteers are provided with the ID ?
Special population associated with
card that is to be presented by them every renal & hepatic impairment,
time they wish to participate in a study. hypogonadal, obese & geriatric
volunteers
?
Female population including
postmenopausal women

6. Bioequivalence and Bioavailability Studies
Lotus has experience of handling more than The experienced and friendly staff makes sure
1400 bio studies for different indications to maintain the safety and well being of the
including First in Man studies, Drug Drug volunteers. There is a 24 Hrs Ambulance
Interaction, Food Effect Studies, complex with a driver dedicated to all the clinics to
studies, studies involving long days of manage any SAE. All the Lotus facilities have
housing, conducting studies in female the advantage of being located near or in
volunteers and pediatric population. The the vicinity of Super Specialty Hospitals and
studies involving patients and special the maximum time to reach the nearby
populations are conducted in liaison with hospitals is not more than 5 minutes.
the specialists Investigators and GP’s. The
availability and our good relationship with
the hospitals enable better recruitment,
compliance and conduct of these studies.
Each of the Clinics have separate area
for Screening, Change Room with Lockers,
Housing, Entertainment, Phlebotomy, Sample
Separation, Storage and Dining.

7. Central Lab Services
Central Lab at Lotus is CAP (College of American Pathologists) and NABL (National
Accreditation Board for Testing and Calibration Laboratories) accredited in accordance with
the international standards ISO 15189, to support the in house requirement as well as to cater
as a stand alone service to the Pharmaceutical requirements.
Located in Lotus House, the lab is spread over 1400 sq. ft and the infrastructure includes
state-of-the-art equipment and experienced staff.
The services include the analysis of samples
for the following parameters:
Hematology, Coagulation, Biochemistry,
Serology Clinical Pathology, Hormone Assays,
Specialized Tests for clinical Trials.
LIS (Laboratory Information System) ensures the
security and integrity for online data transfer.
Biometrics
Lotus has a full-fledged team for Protocol Writing, Report Writing and Statistical Analysis
for Statistical analysis WinNonlin Version 5.0.1 is used, for SAS version 9.2 and SDMS
(scientific Data Management System) 7.0 is used to manage the data generated. Lotus has
experience of submitting the study reports in format as per the regulatory submissions i.e; for US
(ICHE3 with eCTD format), Brazil (ANIVSA format), European (ICHE3), Canada, TGA and Swiss
Regulatory specific formats. MedXview software is used for direct eCTD submission.
Regulatory Services
Lotus has a dedicated team for regulatory and audit compliance to give the best solutions
to our client’s requirement. The in-depth knowledge of local regulatory procedures and effective
liaison with the regulatory agency, our regulatory team ensures efficiency in the clinical trial
approval process. The range of services provided is as follows:
? regulatory strategies
Formulating ? NOC for export of
Obtaining
? the clinical trial application
Compiling biological samples
? and following-up the
Submitting ?of applications and approvals
Tracking
application ?
Safety Reporting
? to regulatory agency
Responding ? of Clinical Safety Report
Submission
queries (CSR)
? drug importation licenses
Obtaining ?of Import License
Renewal

8. Phase 1- First in Man Studies
A state-of-the-art, fully equipped Phase I unit is located inside the campus of St. John's Medical
College and Research Institute, Bangalore, for conducting its Phase I - first in man studies.
St. John's is a 1200 bed hospital and research institute. It is ranked among the top medical
colleges in India.
Lotus' Phase I Facility
12 fully equipped beds
Equipment:
Central Cardiac Monitoring Unit
Defibrillator
Central Nursing station
Oxygen & suction lines
Crash Cart
Lotus has conducted
several
?first in man studies
Phase I -
?
Single Ascending Dose Studies
?
Multiple Ascending Dose Studies
? Interaction Studies
Drug-Drug
Ideal facility for conducting
Phase I - First in Man Studies ? Studies
Food Effect
situated inside campus of a ? Studies including Vaccines,
Biogenerics
tertiary hospital. Immunoglobulin & Erythropoietin
?
Renal impairment studies
? point studies for USFDA
Clinical end
submission involving more than
84 sites & 2400 patients

9. Other Capabilities within
Phase I / II
?
Study design
?preparation
Protocol
?
Biostatistics
? submissions
Regulatory
?
Medical writing
? services
Monitoring
? Safety Monitoring
Medical &
Therapeutic Areas
Phase I / II
?
Oncology
?
Vaccines
?
Cardiovascular
?
Respiratory
?
Dermatology

10. Clinical Development Services
? to III Clinical Trials
Phases: I
Comprehensive range of services
including clinical end point studies
to global pharmaceutical and
? (India, Bangladesh)
230 sites biotech companies for managing
? subjects
Over 7400 Phase l to Phase lll clinical trials
?
FDA submission studies within the Indian sub-continent
Lotus offers following benefits
?infrastructure to manage
Excellent ?
State-of-the-Art Phase I Facility inside the
Clinical Trials campus of St. John's National Academy
? rich & varied professional
Team with of Health Sciences, a leading
experience multi-speciality hospital in Bangalore
?
Rapid recruitment rate ? patients in major
Access to
therapeutic segments
? in various therapeutic
Expertise
segments ?around time
Fast turn
Feasibility
Assessment
Study Regulatory
Monitoring Affairs
Statistical Service Site and Supplies
Services Offerings Management
Project
Management Central Lab
Medical
Writing

11. Clinical Facilities
LOTUS HOUSE
Corporate Office
Bio Analytical Facility: 14 LCMS/MS, 4 HPLC
More than 250 methods developed and validated.
Clinical Facility: 74 Beds (3 wards)
Central Laboratory Services (CAP & NABL accredited)
Total area: 60,000 sq.ft
St. John's Clinical Facility:
Total Area: 25,000 sq. ft.
Clinical Facility: 84 Beds (3 wards)
State-of-the-Art Phase I Facility - 12 Beds
Located in a separate building inside the
campus of St. John's National Academy
of Health Sciences, Bangalore
Chennai Clinical Facility:
Total Area: 11,000 sq.ft.
Clinical Facility: 80 Beds (2 wards)
Jakkur Clinical Facility:
Total Area: 30,000 sq.ft.
Central Facility: 120 Beds (3 wards)
Key Contacts
Dr. Yati Chugh
Managing Director
Email: ychugh@lotuslabs.com
Tel: +91 080 65658452
LL/CB/0911/GDU
P Prasad Rao
.
Sr. Manager - Business Development
LOTUS
Centre of Excellence for Clinical Research
Email: prasad_rao@lotuslabs.com
Tel: +91 080 65738922
Mob: +91 9945158884
LOTUS LABS PRIVATE LIMITED Arvind Koul
Lotus House Assistant Manager Business Development
No. 07, Jasma Bhavan Road, Millers Tank Bed Area, Email: arvind_k@lotuslabs.com
Opp. Gurunanak Bhavan, Vasanthanagar, Mob: +91 9740799778
Bangalore - 560 052. INDIA
Ph Nos.: +91-80-22370912/13/14/15 info@lotuslabs.com
Fax No.: +91-80-22370911 www.lotuslabs.com