innovating solutions for pharma research & development
DESCRIPTION
Lotus Labs is a Clinical Research Organization with extensive experience in conducting Clinical Trials in healthy volunteers, patient populations and special populations.TRANSCRIPT
LOTUSCentre of Excellence for Clinical Research
Innovating Solutions for
Pharma Research & Development
...to be the most admired clinical research organization from India
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
accreditation from CAP and is now serving as The centralized BIO ANALYTICAL lab located Central Lab for Global Clinical Trials.in Bangalore operates in more than 20,000
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.
Services Offered
Lotus offers an array of services to cater the pharmaceutical and
biotech organizations.
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Study Design Pharmacokinetics
(Healthy & patient population)Protocol Writing
Statistical servicesHuman Bioavailability studies
Medical writingBio equivalence studies
Special population studies - Food effect studiesHepatic & Renal impairment etc.
First in man studiesBiogenerics/ Biosimilars
Phase I - Phase III clinical trialsRegulatory Services
Bioanalysis Pharmacy Services (>250 methods validated)
Central Lab ServicesData management
These services involve:
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AGES, Austria
USFDA ANVISA, Brazil
EMEA MCC, South Africa
AFSSAPS, France MOH, Turkey
WHO MCC, Zimbabwe
Drugs Controller General of India
Recruitment and Volunteer Database
Inspections
Lotus has successfully completed more than 40 audits from Indian & International Regulatory Agencies
Lotus has been approved for submission of studies to Sudan and Israel.
Ample explanation and time for signing the
consent form in the vernacular as well as
English is done to make sure of the volunteers
right to information.
Currently Lotus maintains a
population of:
More than 35,000 normal healthy
adult active volunteers in the database
Non smokers
Special population associated with
renal & hepatic impairment,
hypogonadal, obese & geriatric
volunteers
Female population including
postmenopausal women
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The Recruitment Team and the Screening
team manage the recruitment of the
volunteers and maintain a database of all
the volunteers registered and participated in
the studies at Lotus.
Screening and Enrolment of the volunteers is
done through “biometric” finger print system
that registers the basic information of the
volunteer incase he/she had participated in
studies earlier at Lotus Labs. After registration,
all the volunteers are provided with the ID
card that is to be presented by them every
time they wish to participate in a study.
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.
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:
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Formulating regulatory strategies Obtaining NOC for export ofbiological samplesCompiling the clinical trial applicationTracking of applications and approvalsSubmitting and following-up the
application Safety Reporting
Responding to regulatory agency Submission of Clinical Safety Reportqueries (CSR)
Obtaining drug importation licenses Renewal of Import License
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.
Central Lab Services
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.
Equipment:
Central Cardiac Monitoring Unit
Defibrillator
Central Nursing station
Oxygen & suction lines
Crash Cart
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.
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Phase I - first in man studies
Single Ascending Dose Studies
Multiple Ascending Dose Studies
Drug-Drug Interaction Studies
Food Effect Studies
Biogenerics Studies including Vaccines,
Immunoglobulin & Erythropoietin
Renal impairment studies
Clinical end point studies for USFDA
submission involving more than
84 sites & 2400 patients
Lotus' Phase I Facility12 fully equipped beds
Lotus has conducted several
Ideal facility for conducting Phase I - First in Man Studies situated inside campus of a tertiary hospital.
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Oncology
Vaccines
Cardiovascular
Respiratory
Dermatology
Therapeutic Areas Phase I / II
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Study design
Protocol preparation
Biostatistics
Regulatory submissions
Medical writing
Monitoring services
Medical & Safety Monitoring
Other Capabilities within Phase I / II
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Phases: I to III Clinical Trials
including clinical end point studies
230 sites (India, Bangladesh)
Over 7400 subjects
FDA submission studies
Clinical Development Services
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Excellent infrastructure to manage State-of-the-Art Phase I Facility inside the
Clinical Trials campus of St. John's National Academy
of Health Sciences, a leading Team with rich & varied professionalmulti-speciality hospital in Bangaloreexperience
Access to patients in majorRapid recruitment ratetherapeutic segments
Expertise in various therapeuticFast turn around timesegments
Lotus offers following benefits
Comprehensive range of services
to global pharmaceutical and
biotech companies for managing
Phase l to Phase lll clinical trials
within the Indian sub-continent
Service Offerings
Study Monitoring
Regulatory Affairs
Site and Supplies Management
Central Lab
Medical Writing
Project Management
Statistical Services
Feasibility Assessment
LOTUSCentre of Excellence for Clinical Research
Lotus HouseNo. 07, Jasma Bhavan Road, Millers Tank Bed Area, Opp. Gurunanak Bhavan, Vasanthanagar, Bangalore - 560 052. INDIA Ph Nos.: +91-80-22370912/13/14/15Fax No.: +91-80-22370911
LOTUS LABS PRIVATE LIMITED
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)
Dr. Yati ChughManaging Director
Email: [email protected]: +91 080 65658452
P. Prasad RaoSr. Manager - Business Development
Email: [email protected]: +91 080 65738922Mob: +91 9945158884
Arvind KoulAssistant Manager Business Development
Email: [email protected]: +91 9740799778
www.lotuslabs.com
Key Contacts
LL
/CB
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11/G
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