BUSINESS PRESENTATION

2019
Extended Hand for Clinical Research and Pharmaceuticals Partners
India’s Most Respected Organization
Who We Are

• MoniTask is an integrated consultancy and offering

Independent Monitoring and Auditing Services,
Bioanalytical Services, GCP and GLP Training, CRO
• Set up company
MoniTask which consultancy
is an integrated is based atand
Ahmedabad,
offering Clinical Services, Bioanalytical
India.
Services, GCP and GLP Training, CRO Set up company which is based at Ahmedabad,
• MoniTask
India. is an ISO 17100:2015 and ISO 9001:2015
certified company.
• MoniTask is an ISO 17100:2015 certified company.
• At MoniTask we offers best expertise in the Clinical
and Bioanalytical Research industry
Our Vision and Mission…
Our vision is to make and create significant &
positive difference in the overall needs of our Users
and to become an acclaimed market leader in the
field of solution services.

Our mission is to train and engage people &

resources of MoniTask in providing the highest
standard and degree of Clinical Research
solutions to its customers with consistent
 Artisan of MoniTask…

Mr. Vishal(M. Pharm, Pharmacology) is skilled clinical researcher with

and international and national track record of success in progressively
• Feature
responsible position in clinical research environments. Experienced1 in
monitoring multiple site location, clinical site evaluation, initiation,
• Feature
maintenance and close /outs visit in accordance with GCP and
2
• Feature
international regulatory requirements. While ensuring integrity3 and
study data including following study timelines. Skilled in applying
applicable clinical research regulatory requirements such as GCP and
ICH guidelines. Clear awareness of diverse backgrounds alert to widely
varied patient / healthy volunteer needs and circumstances. Extensive
knowledge of clinical trial management systems as well as the design
and implementation of clinical Plans. He was also key allied healthcare
auditor who set up CRO in India and abroad.
 Artisan of MoniTask…
Mr. Shailendra Gupta is associated with MoniTask and having
expertise of Bioanalytical field with 22 years of experience.
With a strong background in LC/MS, He is highly recognized
within the bioanalytical community for contributions
• Featureto1Data
Integrity practices in industry. He has served to several
committees and vocational groups that are • influential
Feature to2 the
progress of bioanalytical science, ex-operational head of
Lambda Therapeutic Research.
• Feature 3
Mr. Shailendra Gupta has capacity of a chief Bioanalytical expert in MoniTask
having 22 year experience with a strong background in LC/MS, Shailendra is
recognized within the bioanalytical community for contributions to Data Integrity
practices in industry. Shailendra serves on several committees and vocational
groups that are influential to the progress of bioanalytical science. He has handled
team of 200+ employees.
 Artisan of MoniTask…

Dr. Dolly Prajapathi (Pharm D.) is a skilled Monitor and Auditor. She
is graduated from SRM University, Chennai. She was previously
• Feature
associated with Accenture Chennai as a Medical Service 1
Associate
and Case processor. She has also worked as Research Associate at
• Feature 2
SRM Medical Hospital and Research center. Ms. Dolly has expertise
hands in Clinical Research and Adverse event/SAE• Monitoring
Featureand 3
Reporting.
 Artisan of MoniTask …

Dedicated Team : We have dedicated qualified team for Monitoring and Auditing,
Training and Consulting, Who can carry monitoring and Auditing, Bioanalytical services
and CRO Set up services. • Feature 1
• Feature 2
• Feature 3
Services We Offer…

BA/BE Monitoring/ Clinical Trial Monitoring01/Patient

Based PKPD study Monitoring

02 Bioanalytical Services, Method Development,

Bioanalytical Set up
03
System Audits /Facility Audits/GCP Audits/GLP
Audits / GMP Audits/QMS Audit

04
GCP/GLP/c-GMP/GXP Training

05
CRO Set up services
Our Expertise Team and Experiences…

01
Clinical Team of More than 10 Years of experience

02 Have Monitored 300 BABE/PKPD Studies.

Have Bioanalytical expert with more than 20 years of experience.

03
Have developed nearly 700 Bioanalytical Methods developed.

04
Have faced 200 sponsor audit successfully.

Have conducted 40 training and consulting programs (GCP, GLP). 05

More than 50 Regulatory Audits faced.

01. Monitoring And Auditing
Our Clinical phase monitoring services ensure the conduct of study in compliance with
regulatory, protocols, SOPs, contracts, agreements and other written procedures. We also
assess the adherence of Good clinical practices at clinical study site. Our Clinical phase
monitors have real time experience in BA/BE clinical phase CROs.
Clinical Phase Review Includes :
We ensure the data integrity
 Regulatory and IEC approvals and ethical standards
 Trial master file and investigational products followed at all the stages of
 Protocols and agreement compliance bioavailability and
 Registration and selection criteria bioequivalence study
 Subject enrolment and dosing conduct to assure the
 Sample collection and transfer sponsor with scheduled
 Storage conditions and tracking details audit agenda shared with
 Case reports and consent forms clinical study centre.
 Safety and wellbeing of subjects
 GDP and GCP compliance
01. Monitoring And Auditing
MoniTask conducting System and Facility audits with well experienced professionals from
regulatory environment. Our Inspectors evaluate and qualify the site for quality compliance,
adherence to the procedures, sponsor obligations and breach of regulations. Under
qualification audit we cover all the divisions of organization for approval and authorization of
Clinical and Bioanalytical project management.
Qualification audits in other areas include :
Qualification Audits Include s:
 Pre Inspection Audits
 Management and Operations strategy  GCLP Mock Audits
 Regulatory approvals and refusals  Site Specific Audits
 Clinical facility
 Bioanalytical Laboratory  Annual Quality Assurance Audits
 Quality Assurance
 PK and Statistics Qualification audits of Vendor
 Quality Control
 Information Technology  Central / Special Laboratories
 Archival Facility  Logistic Support Organization
 Sample Storage Facility  Translation Agency
 Administration and Maintenance
 Supply Chain Management  Calibration Agency
 O3rd Party Archival
02. GCP and GLP, RBM, EC Training
We offer an extensive range of training which include the following
GCP Training
 Introduction to GCP
 Monitoring and Auditing Clinical Laboratories
 GCP Compliance for Monitors / Ethics Committee
 Advanced Quality Assurance
 Good Clinical Laboratory Practice (GCLP)
GLP Training
 GLP Training for Test Facility Management
 GLP Training for Study Directors and study staff
 Conduct of Multi-site studies in compliance with GLP
 Advanced Quality Assurance
 Implementing GLP in your Company
 Advanced GLP (the real issues)
 GLP in the Laboratory
 Good Clinical Laboratory Practice (GCLP) training for organizations and laboratories
which process and analyze samples from Clinical Trials.
03. Bioanalytical Services
Our experienced team has decades of bioanalytical method development and LC/MS/MS
experience. Our scientists are capable of rapidly solving complex bioanalytical problems by
utilizing leading edge technology and state-of- the- art techniques. We develop and validate
robust quantitative bioanalytical methods in numerous biological matrices including whole
blood, plasma, urine, other fluids and tissues. We apply those methods to high-throughput
sample analysis while supporting your GLP and non-GLP studies.
Our Team has Experienced to Develop Below Described Methods

 Total and Free Drug Analysis  Total and Free Drug Analysis
 Multiple Analytes 2,3,4 or 5  Derivatization Method
 Very Low Detection (Around 1pg / ml)  Handling of Unstable Molecule
 Separation of Glucoronide and Different  Chromatographic method of Glauconite
 Chiral Method
Metabolites
 Isomer Investigation
 Analysis of Vitamin (D3, K)
 Bisphosphonates
 Hormones
04. CRO Set up Services
Bioequivalence Centre Setup/ Establishment
We can help you to setup/establish new BE centre / CRO / Bioanalytical
Lab/Clinical Facility. We have decades of experience in BE centre setup. We
can give end to end BE centre setup support, from layout design to practical
training to your employees.

Bioequivalence Training
We believe in training with a practical approach as the key to BE study
success. We have a strong team who have experience in giving hands on
practical training, class room training and online training on BE and related
topics.
Bioequivalence (BE) Study Management
This service will ensure complete study compliance and will increase the study success rate. We provide
end to end services, from protocol initiation to responding regulatory queries, which includes timeline and
data quality management. We will work as single point of contact for all BE study requirements. We will co-
ordinate between sponsor and CRO to maintain timeline and quality. The study will be monitored by our
experienced consultants and we will review 100% study data before sharing final report.
An ISO 9001:2015 and ISO 17100 : 2015
certified
Value Which We Trust
Join Hands With US
MoniTask Pharma services,
F-317, Sumel-6, Near Hanumanpura BRTS, Dudheshwar Road, Ahmedabad, Gujarat
380004

Dr. Dolly Prajapathi

drdolly@monitask.in +91-6359622244

Mr. Vishal Jain

vishal@monitask.in +91-6359622277

Mr. Shailendra Gupta

shailendra@monitask.in +91-9825613718

Website: www.monitask.in