Dutech clinica final

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DUTECH CLINICA

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SUBMISSION REPORTWe hereby submit our project report on Dutech Clinica, Site Management organization from a Sponsor’s Perspective.

Our Team Members are:

Miss. Ursula FurtadoMiss. Kanchan BhagwatMiss. Pranali DaveMiss. Kanchan GoswamiMiss. Chetna KatwateDr. Reshma Kotian

Submitted to : Dr. Kajal Sachdev

Date: 08/12/2014Place: ICRI- Mumbai

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We would like to express our deepest appreciation to all those who provided us the possibility to complete this report.  A special gratitude to our mentor and guide, Dr.Kajal Sachdev, whose contribution in stimulating suggestions and encouragement, helped us to coordinate our project especially in presenting and writing this report.

Furthermore, we would also like to acknowledge with much appreciation the crucial role of Regional Head- Mumbai,ICRI Research Pvt Ltd.Mrs. Sonali Sriram, who gave the permission to use all required  equipment and the necessary materials to complete the project. We have to appreciate the guidance given by her as well in our project presentation that has improved our understanding of the topic to a good extent and also improved our presentation skills thanks to her comment and advices.

We extend our gratitude to our lecturer, Mrs. Akansha Singh for her continuous support and guidance.

Lastly, a special thanks goes to our competitor team mates for the competitive spirit and going beyond competition and appreciating our hard work.

ACKNOWLEDGEMENT

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TABLE OF CONTENTSTOPICS (AS PER SYLABBUS)

PRESENTED BY SLIDE NO.

INTRODUCTION TO SMO MISS. URSULA FURTADOVICE PRESIDENT, DC

3 – 7

CLINICAL TRIAL PROJECT PLANNING AND MANAGEMENT

MISS. KANCHAN BHAGWATSR. PROJECT MANAGER

8 – 14

CLINICAL TRIAL FEASIBILITY MANAGEMENT

MISS. PRANALI DAVEFEASIBILITY ANALYST

15 – 18

CLINICAL RESEARCH CO-ORDINATOR

MISS. KANCHAN GOSWAMISR. CRC

19 – 21

QUALITY CONTROL MANAGEMENT

DR.RESHMA KOTIANQUALITY ANALYST

22 – 30

CLINICAL TRIAL MASTER FILE AND DOCUMENT MANAGEMENT

MISS. CHETHNA KATWATEMASTER FILE MANAGER

31 – 33

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OVERVIEWDutech Clinica is a pioneering institution of world-class investigator sites in India. It is a chain of investigator sites having an exclusive set up for conducting Phase I to Phase IV clinical trials. This model functions as an independent unit and, at the same time is closely attached to a fully equipped multi-specialty hospital.

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OUR USP We have a track record of on-time “delivery” of the contracted

number of Trials performed.

We have a highly competitive project management team

High quality data with regulatory compliance

Cost effective

Ability to rapidly recruit large numbers of patients

High degree of patient retention

Standardized processes

Trained Staff

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OUR CODES OF CONDUCTDC has committed itself to adhere in all its promotional activities to the rules/codes set by the following associations:

The Indian GCP

ICMR guidelines

Schedule-Y

The Local Regulatory Authorities

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OUR SERVICES

Patient Screening and Recruitment

Clinical Operations and Project Management

Investigator Training

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We at DC aim at a better Quality of Life for the people we serve.

We have handled studies involving Outpatients focusing mainly on the following Therapeutic Areas:

Type 2 Diabetes

Hypertension

Obesity/Nutrition

Asthma

Rheumatoid Arthritis

Our Ongoing Trial is a study on RA to find out the efficacy of the IND in question compared to its existing Injectible supplement.

OUR SERVICES

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PROJECT MANAGEMENT• At DC, we have an excellent Project Management team of 30

professionals.

• In our current ongoing trial on RA, we have a highly motivated team working towards achieving credible and accurate data and in turn serving our patients and our sponsor.

• Patient pool for this study is small so retaining the existing patient is a major challenge.

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RESOURCES

Manpower

Money

Materials

Machines

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PROJECT SCHEMEInitiation Planning &

Design Closing

Note: Projects are usually temporary

Executing

Monitoring and Controlling

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PROJECT INITIATION

Development of project proposal

Development of Project Charter

Determine Budget

Create Project Team

Align the project's goals

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PROJECT PLANNING AND DESIGN

• Timelines

• Milestones and deliverables

• Key stakeholders

• Vendor Selection

• Planning Activities

• Planning Documents

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GANTT CHARTS

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PROJECT EXECUTION

Approvals/Permissions

Distribution to site

Start-Up Activities

On-site activities

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FEASIBILITY ANALYSIS MANAGER

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At DC, we have a separate feasibility management team working on different trials to ensure that the timelines are met appropriately.

For our current RA trial, budget flexibility is a major concern as each patient screening and visit would require extensive laboratory procedures and individual transportation.

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Ethical considerati

ons

Protocol

Staff

Scientific considerati

ons

Patient pool

Negotiation time-lines

Regulatory considerati

ons

Study design

Budget feasibility

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MARKET POTENTIAL The market in 2005 was 10croresRs and rose to 22 crores Rs

in 2010. As per the data from 2011-2013, SMO business has grown 20% as against the global average of 12%. The numbers of clinical trial contracts have doubled in last six months (270 to 600).

This ensures a great business for SMO's which are growing at 50% in the country. The SMO's acquire 30% of the Rs 500 Crore recorded by CRO segment.

(Hypothetical)

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CLINICAL RESEARCH COORDINATOR

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CRC

APPROVALS

PRE TRIAL DOCUMENTATI

ON

INVESTIGATORS MEETING

MONITORING

REPORT AND RECORD

AMENDMENT

LAB RESPONSIBILITI

ES.INVESTIGATORS MEETING.

FINANCIAL RESPONSIBILITI

ES.

ICF

SITE INITIATION VISITS.

TRAINING OF THE SITE STAFF

ASSIST IN SUBJECT

RECRUITMENT.

TRAINING OF NEW CRA.

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DC has a strict set of rules and regulations which we adhere to throughout.

Patient care is of utmost importance and ethics are closely followed.

In our current ongoing RA trial, till date our timelines have been met, there are less number of patient fallouts and a good rapport is maintained with the vendors and the staff.

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QUALITY CONTROL

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“Doing it right when no one is looking” is the quality policy at DC.

We at DC, are committed to provide accurate and credible data to maintain high quality standards for a healthier world.

We further assure to adhere to current Good Clinical Practice and regulatory requirements to pioneer good quality products for those who need it the most.

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Data Integrity

Subject Protectio

n

Quality Objectiv

es

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Systems with procedures that assure the quality of every aspect of trial should be implemented

5.1.3: Quality Control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly

INDIAN GCP ON QC

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ALCOA Essential Characteristics of “Quality Data”:

- Accurate(audit trail, accurately captured data)

- Legible(easy to read, easy to comprehend)

- Complete & Contemporaneous(avoid blank data fields, audit trails should mention time)

- Original(source data, original data form lab

-Attributable(representing the actual information

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Quality systems

Personnel roles and

responsibilities

Policies and Procedures

Quality assurance and

auditing

Training

Document Management

Record Retention and

Reporting

CAPA

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Identify the problem

Plan

Do

Check

Act

Root-cause analysis

Applying planned changes

Monitoring & Observing

Apply rules

Repeat processIf problem notresolved

PROCEDURE

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TOTAL QUALITY MANAGEMENT

SUCCESSFUL TRIAL

TIMELY APPROVALS

ENSURE DATA ACCURACY

CONTINOUS IMPROVEMENT

TQM PROGRAM

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QUALITY COMPROMISE

- Failure to follow investigational plan- Protocol deviation- Inadequate record keeping- Inadequate accountability of IP- Inadequate subject protection- Adverse Event recording and reporting

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MASTER FILE MANAGER

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TRIAL MASTER FILE CONTAINS

TRIAL MASTER FILE

PROTOCOL AMENDMENT SIGNED

INVESTIGATORS BROCHURE

STANDARD OPERATING

PROCEDURES

FDA FORM 1572

QUALIFICATION CERTIFICATES & CV

IND SAFETY RECORDS

DECODING PROCEDURES

MONITORINGREPORTS

SOURCE DOCUMENT

INSURANCE STATEMENT

IRB MEMBERS LIST

ICF APPROVED BY IRB

CASE REPORT FORM

TELEPHONE LOGS

IP IVENTORY

AUDIT REPORT

CLOSE OUT REPORT

CLINICAL STUDY REPORT

VISIT LOGS

LAB CERTIFICATIONS

AE,ADR,SAE

REPORTING

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STUDY FOLDER CONTAINS

STUDY FOLDER

ICF

INCLUSION &EXCLUSION CRITERIA

PATIENT CHARTSLAB

REQUISITION FORMS

SCHEDULE OF STUDY

SIGNS & SYMPTOMS TO BE RECORDED

OF ENROLLMENT

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THANK YOU

PRESENTERS:URSULA FURTADO

KANCHAN BHAGWATPRANALI DAVE

KANCHAN GOSWAMIRESHMA KOTIAN

CHETANA KATWATE