Panexcell Clinical Lab Private Limited

Panexcell Clinical Lab Private Limited

CRO offering BA/BE and allied clinical services to pharmaceutical, biotechnology and medical device companies.

Panexcell Clinical Lab Private Limited Our Vision “Our vision is to become a world class CRO by ensuring conformance to highest ethical and quality standards.”

Our Mission “To be one of the most trusted partners to our clients in the pharmaceutical industry through compliance to all regulatory requirements to develop products to improve the quality of human life.” “To build long-lasting relationships with our clients by providing quality data in a timely and cost-effective manner through our team of experienced and dedicated professionals.”

Key Personnel Name

Designation Qualification Experience

Area of specialization

Medical Advisor

Ph.D.

30

Biochemistry

Mr. Nelson Varghese

Head-Technical Operations

M.Sc.

20

Organic Chemistry

Dr. Ajaykumar Malle

Principal Investigator

M.B.B.S.

12

BA/BE studies , Phase III trails, Medical writing.

Dr. Bharat Raut

Head – Bioanalytical

Ph.D.

24

Chemistry

Head – Quality Assurance

Ph.D.

10

Analytical Chemistry

AM – Clinical Trials

B. Sc. & PG Dip Clinical Research

5

Clinical Trials

Dr. Satish Bhatia

Dr. Suvarna Bhoir

Mr. Nishant Lal

Organogram

Infrastructure Premises: • In 2006 at Rabale (Navi Mumbai – India) • Area – 20000 sq. ft.

Clinical Facility: • 58 beds • 2 beds (Emergency Care Unit)

Bio-Analytical Facility: • 7 LCMS/MS (2 API 5500, API 4000, API3200, 2 API 3000, Thermo Discovery)

Employee Strength: • Above 110 personnel

Clinical Units

• • • • • • • • • • • • • •

Spread over 8000 sq. ft. space. 2 air-conditioned wards with a total of 58 beds. Access control for male and female wards. Database of more than 9000 healthy volunteers including 750 female volunteers. Fully equipped ECU facility. Remote monitoring with CCTV. Phlebotomy room with separate matrix processing room. Pharmacy with controlled access. Dining area with in-house kitchen. Screening room. Counseling room with audio-video recording facility. Ambulatory room. Examination & Monitoring rooms. Recreation hall.

Bio-analytical Unit

• Spread over 4000 sq. ft. space • Wet lab with multiple processing counters • Dark room for light-sensitive molecules • LCMS/MS Lab with instrument. • Equipment's and software's, 21 CFR part 11 compliant • Micro-balance room • Chemical storage room • Remote monitoring with CCTV • Data management.

Bio-analytical instruments •

• • • • • • • • •

LCMS/MS: • API 5500 (2 no's) • API 4000 • API 3200 • API 3000 (2 no's) • Discovery (Thermo Finnigan) UV spectro/micro-plate reader Fume hood (2 no's) Automated evaporator (2 no's) Analytical balance Micro balance Refrigerated centrifuge (3 no's) Deep freezers (9 no's) Eurotherm data logger Water purification system

Utilities

• Fully air-conditioned facility • Multiple Power back up generator with100kva and 20kva capacities • UPS for all instrumentation and computers • Scroll pumps and nitrogen generators

Ethics committee EC IEC for new drug approvals No

Name

Qualification

Designation

1

Dr. Walavalkar

M.B.B.S.; M. D. Pharmacologist Physician

Chairperson Member Scientific

2

Dr. Rajalaxmi

M.B.B.S., DGO, DFP, FCPS, DNB, MRCOG, FICMCH; M. D

Secretary Member Scientific

3

Dr. Sinha

M.B.B.S.; M. D. Pharmacologist Physician

Member Scientific

4

Dr. Shaikh

M.B.B.S., DVD, FCPS, DNB Clinician M.B.B.S., DPD –UK

Member Scientific

5

Dr. Karkbanis

M.B.B.S., DPD -UK DPSE- Australia, M.D.-DDM-AM Clinician

Member Scientific

6

Adv. Kulkarni

B. A., L.L.B. Lawyer

Jt. Secretary Member Scientific

7

Dr. Jawle

M.A., B.Ed., Ph.D. Educationist, Philosopher

Member- Legal

8

Mr. Balankhe

B. Sc., Lay person Representing Public

Non Scientific Member

9

Mrs. Kulkarni

M. A. M. Ed., Lay person Representing Public

Non Scientific Member

10

Mrs. Limaye M.P.

M.S.W. Social Worker

Non Scientific Member

Ethics committee Ethos for old drug approvals Sr. No

Name

Qualification

Designation

Ph.D (Pharmacology)

Chairperson

M.D (Pathology)

Basic medical scientist

M.D (Pharmacology)

Basic medical scientist

M.B.B.S, DCH

Clinician

M.B.B.S, M.D, DCH

Clinician

M. Pharmacy

Member Secretary

1

Dr. Addepalli V.

2

Dr. Milind Chincholkar

3

Dr. Baliram Ghodke

4

Dr. Puneet Gupta

5

Dr. Satishkumar Thakur

6

Mr. Girish Parmar

7

Ms. Padma Karulkar

LLB

Legal

8

Ms. Kirti M.

LLB

Legal

9

Mr. Manohar Ayare

S.S.C

Layperson

10

Ms. Deepika Mehta

H.S.C.

Layperson

11

Mr. Shashikant Gondegaokar

S.S.C

Social Worker

12

Ms. Tejal Parekh

M.Com

Social Worker

Sub-contracts (Outsourcing)

Sr. No.

Name of Sub Contractors

Activity outsourced

1

Getwell Diagnostics Lab

Pathology test

2

Metropolis Lab

Pathology test

3

Dr. Jairaj Diagnostic Centre

Pathology test

4

Alert EC

Ethic Committee

5

Ethos

Ethic Committee

6

Criticare Hospital

ECU, Radiology services

7

Mayuresh Associate

Calibration

8

Navi Mumbai Bio-waste Agency

Bio-waste disposal

9

CSBL

Archival

Services Provides a Broad Range of Services Under “One Roof” Bio-Availability / Bio-Equivalence Studies Clinical Trials Services Pharmacokinetic Studies with NDDS & NCEs Statistical Analysis Data Management Medical Writing Special Population Studies

Services Pharmacokinetic Studies • Single dose and multiple dose kinetics • Oral / Parenteral / Nasal / Aerosols / Local Formulations • Evaluation of Immediate / Controlled / Delayed release dosage forms under Fasting / Food effect • Special population studies (Postmenopausal females)

Therapeutic areas

• Analgesics

• Hypoglycemic agents

• Anti hypertensive

• Immunosuppressant

• Anti Malarial

• Lipid lowering agents

• Antibiotic/ Antimicrobial

• Muscle relaxants

• Anticonvulsant

• Bronchodilators

• Antidepressant

• NSAIDs

• Antiretroviral

• Oral contraceptive

• Cardiovascular

• Psychotropic agents

• Hormones

Quality Assurance

• Quality Assurance at Panexcell is an independent function and ensures ethical conduct of clinical studies as per GCP, GLP & other applicable regulatory requirements. • Approval, review, distribution and implementation of SOPs • Responsible for in-process and retrospective audits • Training the staff on SOPs • Interfacing for sponsor and regulatory audits • Archival

Training Schedule Month

JAN

FEB

General SOPs / Statistical Training

General SOPs

MAR

APR

MAY

JUN

JUL

AUG

SEP

OCT

NOV

DEC

General EOPs

DepartmentalDepartmentalDepartmental SOPs SOPs SOPs

DepartmentalDepartmentalDepartmental SOPs SOPs SOPs

GLP / GCP / Manuals

Regulatory Guidelines

Safety Training

Archival An isolated archival section at PCLPL facilitates reconstruction of study as per regulatory requirement. In-house facility: Panexcell Clinical Lab Private Limited R-374, TTC MIDC, Rabale, Navi Mumbai Third Party archival facility: For hard copy: Capital Records Centre Pvt. Ltd. Dapode village, Taluka Bhiwandi, Mumbai. For soft copy: HDFC Bank Limited Turbhe, Navi Mumbai. & Prism Consultancy Ahmedabad.

List of SOPs General SOPs Sr. No. 1

SOP Title Preparation, Review, Approval, Authorization, Distribution and Revision of Standard Operating Procedure

SOP No. PCLPL-GN-SOP-01-01

2

Training of Personnel

PCLPL-GN-SOP-02-01

3

Document Control

PCLPL-GN-SOP-03-01

4

Change Control

PCLPL-GN-SOP-04-01

5

Documentation, Data Handling and Record Keeping

PCLPL-GN-SOP-05-00

6

Safety at PCLPL

PCLPL-GN-SOP-07-00

7

PCLPL-GN-SOP-08-00

8

Archival and Retrieval Procedure for Assigning Identification Codes to Clinical and Bioanalytical Project Documents

9

General Housekeeping and Sanitary Procedure

PCLPL-GN-SOP-10-00

10

Access Control

PCLPL-GN-SOP-11-00

11

Electricity Supply - Failure Handling

PCLPL-GN-SOP-12-00

12

Equipment Qualification

PCLPL-GN-SOP-14-00

13

Disposal of Waste

PCLPL-GN-SOP-15-01

14

Role and Responsibilities of Personnel at PCLPL

PCLPL-GN-SOP-16-00

PCLPL-GN-SOP-09-00

List of SOPs General SOPs Sr. No.

SOP Title

SOP No.

15

Preparation of Calibration Plan

PCLPL-GN-SOP-17-00

16

PCLPL-GN-SOP-18-00

17

Recording of Temperature and Humidity Defining Units, Number of Digits and Rounding off Procedure for Reporting of Project Data

18

Management Review System

PCLPL-GN-SOP-21-00

19

Data Transfer and Acceptance for Biostatistics

PCLPL-GN-SOP-22-00

20

Quality Control

PCLPL-GN-SOP-25-00

21

Preventive Maintenance of Instruments

PCLPL-GN-SOP-26-00

22

Preparation and Updation of Project Plan

PCLPL-GN-SOP-27-00

23

Procedure for Disaster Recovery

PCLPL-GN-SOP-28-00

24

Procedure for Assigning Identification Number to Instruments

PCLPL-GN-SOP-29-00

25

Preparation and Revision of Organizational Documents

PCLPL-GN-SOP-30-00

26

Handling of Deviations Identification of Non-Conformity and Implementation of Corrective Action and Preventive Action Plan

PCLPL-GN-SOP-31-00

27

PCLPL-GN-SOP-19-00

PCLPL-GN-SOP-32-00

List of SOPs General EOPs Sr. No.

PCLPL-GN-EOP-01-00

2

SOP Title Operation and Maintenance of Emergency Shower and Eye Washer Operation and Calibration and Maintenance of Thermohygrometer

3

Operation, Calibration and Maintenance of Data Logger

PCLPL-GN-EOP-03-00

4

Operation, Calibration and Maintenance of Clocks

PCLPL-GN-EOP-04-00

5

Operation, Calibration and Maintenance of Gas Leak Detector

PCLPL-GN-EOP-05-00

6

Operation and Calibration of Data Logger ebro EBI 300

PCLPL-GN-EOP-06-01

7

Operation and Calibration of Data Logger ebro EBI 20

PCLPL-GN-EOP-07-00

8

Operation of Data Logger RTD-CCMS Procedure for Operation, Calibration, Maintenance and Record Keeping of Data Logger

PCLPL-GN-EOP-08-00

1

9

SOP No.

PCLPL-GN-EOP-02-00

PCLPL-GN-EOP-09-00

List of SOPs Bio-analytical SOPs Sr. No. 1

SOP Title Procurement, Storage, Usage, Maintenance and Disposal of Reference Standards/ Working Standard

PCLPL-BA-SOP-01-00

2

Handling and Maintenance of Chemicals, Reagents and Solvents

PCLPL-BA-SOP-02-00

3

Procurement, Identification and Storage of Biological Matrix

PCLPL-BA-SOP-03-00

4

Procurement, Storage and Maintenance of Analytical Columns

PCLPL-BA-SOP-04-00

5

Labeling Procedure in Bioanalytical Department

PCLPL-BA-SOP-05-00

6

PCLPL-BA-SOP-06-00

8

Cleaning of Laboratory Glass Wares Collection, Storage and Disposal of Laboratory Chemicals and Reagents Acceptance of Chromatographic Data and Verification of Chromatograms

9

Handling of Rejected Chromatographic Data

PCLPL-BA-SOP-09-00

10

Guidance on Bioanalytical Method Development

PCLPL-BA-SOP-10-01

11

Recording of Raw Data in Bioanalytical Department

PCLPL-BA-SOP-11-00

12

Preparation of Stock Solution, Dilutions, CCs and QCs

PCLPL-BA-SOP-12-00

13

System Suitability

PCLPL-BA-SOP-13-00

14

Preparation and Approval of Method Validation Protocol

PCLPL-BA-SOP-14-00

15

Validation of Bioanalytical Methods

PCLPL-BA-SOP-15-00

7

SOP No.

PCLPL-BA-SOP-07-00 PCLPL-BA-SOP-08-01

List of SOPs Bio-analytical SOPs Sr. No.

SOP Title

SOP No.

16

Preparation and Approval of Method Validation Report

PCLPL-BA-SOP-16-00

17

Receipt, Storage, Issuance and Disposal of Samples

PCLPL-BA-SOP-17-00

18

Subject Sample Analysis and Batch Acceptance Criteria

PCLPL-BA-SOP-18-00

19

PCLPL-BA-SOP-19-00

20

Repeat Analysis Preparation and Approval of Bioanalytical Subject Analysis Report

21

Compilation of Raw Data in Bioanalytical Department

PCLPL-BA-SOP-21-00

22

Incurred Sample Re-Analysis

PCLPL-BA-SOP-22-00

23

System Suitability for Ligand Bind Assays Quantitative Ligand Binding Assays : Preparation of Calibration Curve Standards, Quality Control Samples, Assay Specifications and Acceptance Criteria

PCLPL-BA-SOP-23-00

PCLPL-BA-SOP-25-00

26

Recording of Raw Data for Ligand Bind Assay Validation of Bioanalytical Methods by Using Ligand Binding Assays

27

Role and Responsibilities of Custodian

PCLPL-BA-SOP-27-00

28

Preparation and Approval of Method SOP

PCLPL-BA-SOP-28-01

29

Screening of Biological Matrix

PCLPL-BA-SOP-29-00

24 25

PCLPL-BA-SOP-20-00

PCLPL-BA-SOP-24-00

PCLPL-BA-SOP-26-00

List of SOPs Bio-analytical EOPs Sr. No. 1

SOP Title

SOP No. PCLPL-BA-EOP-01-00

2

Operation, Calibration and Maintenance of Pipettes Operation, Calibration and Maintenance of Refrigerated Centrifuge

3

Operation, Calibration and Maintenance of Centrifuge

PCLPL-BA-EOP-03-00

4

Operation and Maintenance of Sonicator

PCLPL-BA-EOP-04-00

5

Operation, Calibration and Maintenance of Refrigerators Operation, Calibration and Maintenance of Deep Freezers (SANYO) Operation, Calibration and Maintenance of Deep Freezers (NEW BRUNSWICK) Operation, Calibration and Maintenance of Sartorius Analytical Balance (Model. CP224S)

PCLPL-BA-EOP-06-00

Operation, Calibration and Maintenance of Turbo Evaporator Operation, Calibration and Maintenance of Mass Spectrometer (Thermo) Operation, Calibration and Maintenance of Mass Spectrometer (Applied Biosystems)

PCLPL-BA-EOP-10-00

Operation, Calibration and Maintenance of Hot Air Oven Operation, Calibration and Maintenance of Solid Phase Extraction (SPE) Processor

PCLPL-BA-EOP-13-00

6 7 8 9 10 11 12 13

PCLPL-BA-EOP-02-00

PCLPL-BA-EOP-07-00 PCLPL-BA-EOP-08-00 PCLPL-BA-EOP-09-00

PCLPL-BA-EOP-11-00 PCLPL-BA-EOP-12-01

PCLPL-BA-EOP-14-00

List of SOPs Bio-analytical EOPs Sr. No.

SOP Title

SOP No.

14

Operation, Calibration and Maintenance of pH Meter

PCLPL-BA-EOP-15-01

15

Operation, Calibration and Maintenance of Micro Balance

PCLPL-BA-EOP-16-00

16

Operation, Calibration and Maintenance of Vibramax 110 vortexer

PCLPL-BA-EOP-17-00

17

Operation, Calibration and Maintenance of Multi Pulse Vortexer

PCLPL-BA-EOP-18-00

18

Operation and Maintenance of Nitrogen Generator

PCLPL-BA-EOP-19-00

19

Operation and Maintenance of Filtration Assembly

PCLPL-BA-EOP-21-00

20

Operation, Calibration and Maintenance of Column Oven

PCLPL-BA-EOP-22-00

21

Operation, Calibration and Maintenance of HPLC Systems

PCLPL-BA-EOP-23-00

22

PCLPL-BA-EOP-24-00

26

Operation, Calibration and Maintenance of Incubator Operation, Calibration and Maintenance of Spectrophotometer(Microplate Reader) Operation, Calibration and Maintenance of API 5500 Mass Spectrometer Operation and Maintenance of Water Purification system (Micropore) Operation, Calibration and Maintenance of Deep Freezer (Make: Haier Medical and Laboratory Co. Ltd. Model No. 86L628)

27

Operation and Calibration of Fume Hood

PCLPL-BA-EOP-29-00

23 24 25

PCLPL-BA-EOP-25-00 PCLPL-BA-EOP-26-01 PCLPL-BA-EOP-27-00 PCLPL-BA-EOP-28-00

List of SOPs Bio-analytical EOPs Sr. No. 28

SOP Title

SOP No. PCLPL-BA-EOP-30-00

30

Operation, Calibration and Maintenance of Conductivity Meter Operation, Calibration and Maintenance of API-3200 Mass Spectrometer Operation ,Calibration and Maintenance of Inductively Coupled Plasma Optical Emission Spectrometer

31

Operation ,Calibration and Maintenance of Centrifuge Machine

PCLPL-BA-EOP-33-00

29

PCLPL-BA-EOP-31-01 PCLPL-BA-EOP-32-00

List of SOPs Clinical SOPs Sr. No.

SOP Title

SOP No.

1

Registration and Enrollment of Volunteer in Volunteer Database

PCLPL-CL-SOP-01-01

2

Obtaining Informed Consent

PCLPL-CL-SOP-03-01

3

Screening of Volunteer

PCLPL-CL-SOP-06-01

4

Handling of HIV, HBsAg , HCV and VDRL Positive Volunteers Transport of Biological Samples to the Pathology Lab and Obtaining Reports

PCLPL-CL-SOP-07-00

PCLPL-CL-SOP-09-01

7

Conducting Test for Drug of Abuse Receipt, Storage, Dispensing, Accountability and Disposal of Investigational Product

8

Initiation of Clinical Project

PCLPL-CL-SOP-11-02

9

Project Master File

PCLPL-CL-SOP-12-00

10

PCLPL-CL-SOP-13-00

11

Conducting Clinical Examination and Vitals Signs Monitoring of the Subjects During Confinement in the Clinical Facility

12

Check-In and Check-Out of Subjects in Clinical Studies

PCLPL-CL-SOP-16-02

13

Serving Standardized Meals to Subjects

PCLPL-CL-SOP-17-01

14

Insertion of Intravenous Cannula and Phlebotomy

PCLPL-CL-SOP-18-01

5 6

PCLPL-CL-SOP-08-00

PCLPL-CL-SOP-10-00

PCLPL-CL-SOP-14-01

List of SOPs Clinical SOPs Sr. No. 15

SOP Title

SOP No.

Dosing Processing, Separation, Storage, Segregation and Transfer of Matrix

PCLPL-CL-SOP-19-00

PCLPL-CL-SOP-21-00

18

Transfer of Biological Samples to Bioanalytical or External Facility Identifying, Monitoring, Recording and Reporting of Adverse Events and Serious Adverse Events

19

Handling of Subject Withdrawal and Dropout

PCLPL-CL-SOP-23-00

20

Post Study Safety Assessment

PCLPL-CL-SOP-24-00

21

Procedure for Blank Bio Matrix Collection

PCLPL-CL-SOP-25-00

22

Management of Pharmacy

PCLPL-CL-SOP-26-01

23

Transfer of Subject to Hospital

PCLPL-CL-SOP-27-00

24

Management of Emergency Care Unit (ECU)

PCLPL-CL-SOP-28-00

25

Preparation of Clinical Summary Report

PCLPL-CL-SOP-29-01

26

Conduct of Clinical Phase of BA-BE Project

PCLPL-CL-SOP-30-00

27

Compilation of Project Documents

PCLPL-CL-SOP-31-01

28

Labeling Procedure in Clinical

PCLPL-CL-SOP-32-01

16 17

PCLPL-CL-SOP-20-01

PCLPL-CL-SOP-22-02

List of SOPs Clinical SOPs Sr. No. 29

SOP Title

SOP No. PCLPL-CL-SOP-33-01

30

Urine Pregnancy Test Compensation to Subjects/volunteers During Clinical Phases At PCLPL

31

Premature Suspension or Termination of A Clinical Study

PCLPL-CL-SOP-42-00

32

Handling of Reserved Subjects

PCLPL-CL-SOP-43-00

33

Role and Responsibilities of Clinical Study Coordinator

PCLPL-CL-SOP-44-00

34

PCLPL-CL-SOP-45-00

35

Operation and Maintenance of Medical Assistance Alert System Conduct of Double Blind Bioavailability/Bioequivalence Studies At PCLPL

36

Conduct of Concurrent Clinical Projects

PCLPL-CL-SOP-47-00

37

PCLPL-CL-SOP-48-00

38

Management of Contractual Staff Measurement of Height, Weight and Calculation of Body Mass Index of Volunteers

39

Conducting Medical Examination

PCLPL-CL-SOP-51-00

40

Role and Responsibilities of Principal Investigators

PCLPL-CL-SOP-53-00

41

Delegation of Responsibilities to Study Staff Preparation, Approval and Use of Promotional Material for Volunteer Mobilization

PCLPL-CL-SOP-54-01

42

PCLPL-CL-SOP-34-00

PCLPL-CL-SOP-46-00

PCLPL-CL-SOP-49-00

PCLPL-CL-SOP-55-00

List of SOPs Clinical SOPs Sr. No. 43

SOP Title

SOP No. PCLPL-CL-SOP-56-00

44

Measurement, Recording and Evaluation of Vital signs Preparation, Filling and Disposal of Saline/Heparinised Saline Solution

45

Management of Emergency Medical Conditions

PCLPL-CL-SOP-58-00

46

Qualitative Detection of Cotinine in Human Urine

PCLPL-CL-SOP-59-00

PCLPL-CL-SOP-57-00

List of SOPs Clinical EOPs Sr. No.

PCLPL-CL-EOP-03-00

2

SOP Title Operation, Calibration and Maintenance of Centrifuge Machine (Make: Heraeus & Model: Multifuge3S-R) Operation, Calibration and Maintenance of Deep Freezer (-20ºc) (Make: Labtop & Model: LBF 350VL

3

Operation and Maintenance of Ambu Bag

PCLPL-CL-EOP-05-00

4

PCLPL-CL-EOP-06-00

5

Operation, Calibration and Maintenance of Glucometer Operation, Calibration and Maintenance of Stability Chamber {Make: Thermolab )

6

Biometric Based Volunteer Management System

PCLPL-CL-EOP-08-00

7

Operation, Calibration and Maintenance of Suction Machine

PCLPL-CL-EOP-09-00

8

PCLPL-CL-EOP-10-00

10

Operation, Calibration and Maintenance of Nebulizer Operation, Calibration and Maintenance of Weighing Scale (Make: Eagle system, Librar system & Electronic Kitchen Weighing SL-801) Operation, Calibration and Maintenance of Height Scale (Make: SM Collo, Oxipod, Libra)

11

Operation and Calibration of Clinical Thermometer

PCLPL-CL-EOP-13-00

12

Operation and Calibration of Sphygmomanometer

PCLPL-CL-EOP-14-00

13

Online Volunteer Information System

PCLPL-CL-EOP-16-00

1

9

SOP No.

PCLPL-CL-EOP-04-00

PCLPL-CL-EOP-07-00

PCLPL-CL-EOP-11-00 PCLPL-CL-EOP-12-00

List of SOPs Clinical EOPs Sr. No.

21

SOP Title Operation, Calibration and Maintenance of Defibrillator{Make: BPL Model No: DF 2509/R} Operation, and Maintenance of Cardiac Multiparameter Monitor {Make:BPL Model:EXCELLO ECO} Operation, Calibration and Maintenance of Stability Chambers {Make: Visco} Operation, Calibration and Maintenance of Digital Breath Analyzer Tester Operation, Calibration and Maintenance of Cooling Centrifuge Machine (Make: Remi and Model: C-30 and Make: Remi and Model: C-30 BL) Operation, Calibration and Maintenance of Deep Freezer (Make: Electrolux and Model: EC-1109) Operation, Calibration and Maintenance of Centrifuge Machine (Make: Heraeus and Model: Heraeus Megafuge 16R) Operation, Calibration and Maintenance of Deep Freezer (-20°C) (Make: Haier and MODEL: DW- 40L508)

22

Operation, Calibration and Maintenance of Refrigerator

PCLPL-CL-EOP-28-00

23

Operation, Calibration and Maintenance of Pipette

PCLPL-CL-EOP-29-00

24

Operation, Calibration and Maintenance of ECG Machine

PCLPL-CL-EOP-30-00

14 15 16 17

18 19 20

SOP No. PCLPL-CL-EOP-17-00 PCLPL-CL-EOP-18-00 PCLPL-CL-EOP-20-00 PCLPL-CL-EOP-22-00

PCLPL-CL-EOP-23-00 PCLPL-CL-EOP-24-00 PCLPL-CL-EOP-26-01 PCLPL-CL-EOP-27-00

List of SOPs Clinical EOPs Sr. No.

SOP Title

SOP No.

25

Operation, Calibration and Maintenance of Pulse Oximeter Operation, Calibration and Maintenance of Defibrillator (MakeMEDTRONIC, Model-LIFEPAK CR PLUS) Operation, Calibration and Maintenance of Cardiac Bedside Monitor {Make: BPL Model} Operation, Maintenance of Labeling Printer (Make : CITIZEN and Model : CL-S700)

PCLPL-CL-EOP-31-00

26 27 28

PCLPL-CL-EOP-33-00 PCLPL-CL-EOP-34-00 PCLPL-CL-EOP-35-00

List of SOPs Medical Writing SOPs Sr. No. 1 2

SOP Title Initiation, Preparation, Review, Approval and Distribution of BA/BE and Related Study Protocols

SOP No. PCLPL-MW-SOP-01-01 PCLPL-MW-SOP-02-01

3

Preparation, Review and Distribution of Informed Consent Form Translation and Back Translation of Informed Consent Form (ICF)

4

Preparation and Completion of Case Record Form

PCLPL-MW-SOP-04-00

5

Submission of Documents to Ethics Committee

PCLPL-MW-SOP-05-00

6

Communication to Regulatory Authority

PCLPL-MW-SOP-06-00

7

Preparation of Final Report

PCLPL-MW-SOP-07-00

PCLPL-MW-SOP-03-00

Statistical SOPs Sr. No.

SOP Title

SOP No.

1

Sample Size Calculation for BA/BE Studies

PCLPL-PK-SOP-01-00

2

Randomization

PCLPL-PK-SOP-02-00

3

Detection of Statistical Outlier

PCLPL-PK-SOP-03-00

4

Statistical Analysis Using SAS 9.3 Or Higher Version Calculation of Pharmacokinetic Parameters Using SAS ® Software Version 9.3 For BA/BE Studies

PCLPL-PK-SOP-04-00

5

PCLPL-PK-SOP-05-00

List of SOPs Quality Assurance SOPs Sr. No.

SOP Title

SOP No.

1

Scheduling of Audit Activities for a Study

PCLPL-QA-SOP-01-00

2

Conducting Audits of Clinical Department

PCLPL-QA-SOP-02-00

3

Conducting Audits of Bioanalytical Department

PCLPL-QA-SOP-03-00

4

Preparation and Release of Audit Report

PCLPL-QA-SOP-04-02

5

PCLPL-QA-SOP-05-00

6

Audit of Final Project Report QA Line Clearance for Investigational Product Receipt, Dispensing and Destruction Procedure

7

Auditing of Vendor Facilities

PCLPL-QA-SOP-07-01

8

System Audit at PCLPL

PCLPL-QA-SOP-08-00

PCLPL-QA-SOP-06-00

List of SOPs Administration SOPs Sr. No. 1

SOP Title Purchase, Issue of Items

SOP No. PCLPL-AD-SOP-01-00

Information Technology SOPs Sr. No.

SOP Title

SOP No.

1

Computer User ID and Password

PCLPL-IT-SOP-01-00

2

Computer Data Backup

PCLPL-IT-SOP-02-00

Manuals / Policies

Site Master File

Quality Manual

Safety Manual

IT Policies

Regulatory submissions BA/BE Studies • More than 900 studies • USFDA submissions:

Zolmitriptan Atazanavir + Ritonavir Iron Sucrose Dapsone Dutasteride Paricalcitol Leucovorin

Regulatory submissions

• EMEA submission:

Metformin Clopidogrel Olanzapine

• MHRA – UK:

Alverine Citrate

• MCC – South Africa:

Levonorgestrel

• WHO:

Atazanavir + Ritonavir

• TGA – Australia:

Clopidogrel

• HSA – Singapore:

Glipizide

Regulatory Approvals Facility Approval

Study Approval

DCGI - India MoH – Turkey

FDA - USA MHRA - UK MCC - South Africa MoH – Malaysia MoH - Kazakhstan HSA - Singapore TGA – Australia

Clinical Trials

• Phase II – USFDA submission NCE for Type II diabetes patients conducted in-house • Phase II – USFDA submission NDDS formulation for patients infested with Head Lice conducted inhouse • Phase II-A – Australian TGA submission NCE for patients infested with Head Lice conducted in-house • Phase I – DCGI & USFDA submission NDDS formulation for breast cancer patients conducted at 5 hospital sites

Clinical Trials

• Phase II – USFDA submission Dermatology (patients with Tinea Pedis) • Phase III – Kazakhstan submission (2 studies) Bacterial infection (antibiotics) • Phase III – Awaiting local regulatory permission for three Clinical Trials.

* (DMRI) Panexcell is already listed on the USFDA Clinical Trial Registry for Dermatology Clinical Trials

Project Management

• Dedicated Project coordinators to provide end to end services to our sponsors • Overall co-ordination from protocol preparation to final report dispatch

Project flow

Study Confirmation

Feasibility Assessment

Agreement with Client

Protocol Preparation

Protocol Approval

IEC submission & Approval

Local Regulatory Approval

Method Development Method Validation

Screening

Clinical Phase (housing, dosing, sampling, discharge, ambulatory sample)

Clinical Data Compilation

Sample Analysis

QA Check

PK Analysis

Statistical Analysis

Stats report + Analytical report + Clinical report

Draft report to QA

Report to IEC

Final Report Dispatch to Client

Archival

Typical timelines Week

W1

W2

W3

W4-7

Study Confirmation & Agreement

Feasibility Assessment

Protocol Preparation

Protocol Review and Approval

IEC submission & Approval

DCGI submission & Approval

Method Development

Method Validation

Method SOP

30 – 45 days

Typical timelines Week IP Receipt

Clinical Phase

Sample Analysis

PK & Statistical Analysis

Final Report Preparation

Final QA check

Final Report to IEC

Final Report Dispatch to Client

W8-9

W 10

W 11

W 12

Clinical Trial Management Flow of Activities

Ethics committee Approvals

• • • •

Regulatory Approvals

Site feasibility Pre Site selection Visit Site Selection Visit Pre Study Documents Collection

• Site initiation Planning • Site initiation Kit Supply to Sites • Site initiation Visit • Site Staff Training

Data Base Cleaning

IP Supply Patient Recruitment and Randomization

Site Monitoring

Source data Verification and CRF Retrieval

Thank you Panexcell Clinical Lab Private Limited (Formerly known as Drug Monitoring Research Institute (P) Ltd.) Contact: R-374, TTC MIDC, Rabale, Navi Mumbai – 400701 India. Tel.: +91 22 3969 7979 Fax: +91 22 3969 7999 E-mail: [email protected] Website: www.panexcell.com