Quality Medical Regulations Services (QMRS)

Knowledge is Power...................................Customer Satisfaction is Our Goal.....................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal.......................................... .......Ethics Approach is Our Mean...................................Knowledge is Power...................................Customer Satisfaction is Our Goal..................................................Ethics Approach is Our Mean...................................

SERVICES

ON-LINE PURCHASE

AVAILABLE GMPs AND CLINICAL TRIALS STANDARD OPERATING PROCEDURES (SOPs)

We are selling many generic documents (Standard Operating Procedures, Audit Checklists, Policies, and Templates)

These documents cover almost all Health Products Good Manufacturing Practices (GMPs) and Good Clinical Practices activities as specified by the International Conference on Harmonization (ICH) and the Regulatory authorities (USA FDA and Health Canada)

This online purchasing option is to provide you with the needed documents regardless of your location.

The following pages contain lists of documents (policies, SOPs, and audit checklists), which you can purchase on line

QMRS On-Line documents support two specific activities that pertaining to food and drug regulations. The activities (Categories) are:

Standard Operating Procedures (SOPs) on Good Manufacturing Practices (GMPs)
Standard Operating Procedures (SOPs) on Good Clinical Practices (GCPs)

DOCUMENTS CHARACTERISTICS:

1.  These documents were written to assist you to prepare your facility for successful regulators inspection (Please see Privacy and Liability for more details).

2.  As indicated before, these documents are Microsoft Word written texts. Therefore, very little efforts might be needed to be specific to your organization.

3.   If you are unable to find a specific SOP or policy (a SOP title or subject) in our website, please let us know as we have many documents, which are under development.

PAYMENT OPTIONS

We offer an easy and secure payment via Pay Pal. You also have the option of paying by Cheque, or bank transfer in Canadian or US Dollar.

1. Pay with Credit Card via Pay Pal

This service is provided by Pay Pal, which provides a secure environment for the processing of on-line credit card transaction by using the most advanced privacy protection technology available.

The process is very simple, just follow the following steps:

a.   Click ‘add to cart’ for the document you choose.

b.   When all chosen documents completed, click on view cart.

c.   After you review all of the cart contents, click checkout.

d.   Now, Pay Pal will take you to their payment details page.

e.   You will be asked to enter your credit card information and email address.

f.    After completion the needed information, you will be taken to a confirmation page containing the details of your payment, where you need to click ‘Pay’ to complete the payment.

g.   When the process completed successfully, you will receive an email receipt for the transaction confirming payment, and a copy of the payment details.

h.   Pay Pal will send QMRS an email notification of your payment.

i.    Upon your payment reflected in QMRS account balance, the document will be transmitted to you electronically (via email).

j.   Please note that you will be able to make credit card payment without signing up for a Pay Pal account.

k. Also, important to know that QMRS address and Bank account is verified by Pay Pal.

2.   Paying by Cheque

We accept certified or draft checks in Canadian, or US dollars. Please make cheque payable to ‘Quality Medical Regulations Services’ addressed to 196 Annapolis Circle, Ottawa, Ontario K1V 1Z1 Canada.

But, please note that we only process orders, when cheque has been received and verified by the bank.

3.   Paying by Bank Transfer

Payment could be sent to TD Canada Trust Bank Account number. Bank address will be provided to you upon your request. Please make sure that your bank’s wire fee is included in the amount transferred. As above, we only process orders when payment has been received, and verified by the bank.

Please note that Canadian clients should add a 5% to the total for the Goods and Services Taxes (Our GST No. is: 85555 2147 RT0001)

CATEGORY ONE

SOPs AND POLICIES ON GOOD MANUFACTURING PRACTICES

STANDARD OPERATING PROCEDURES (SOPs) ON PERSONNEL

PERSONNEL TRAINING

PURPOSE:

The purpose of this document is to establish the minimum training system requirements to enable the corporate personnel to effectively perform their assigned responsibilities and realize the impact of their actions on the Quality Management System.

Code: PER 002

Price: CAD 35.00

QUALITY CONTROL/ASSURANCE PERSON RESPONSIBILITY

PURPOSE:

The purpose of this procedure is to establish and communicate with all concerned departments the Quality Assurance person or his/her designee responsibilities

Code: PER 004

Price: CAD 12.00

SANITATION: EMPLOYEES

PURPOSE:

The purpose of this document is to establish the system (Procedure) to secure that employees who are handling raw or finished materials are clean.

Code: PER 006

Price: CAD 17.00

SANITATION: HAND WASHING

PURPOSE:

The purpose of this procedure is to describe the company minimum hand washing requirements.

Code: PER 008

Price: CAD 10.00

STANDARD OPERATING PROCEDURES (SOPs) ON PHYSICAL PLANT

HOUSEKEEPING

PURPOSE:

The purpose of this procedure is to define the company minimum housekeeping requirements (Describe the general housekeeping requirements).

Code: PLC 001

Price: CAD: 12.00

SANITATION; PEST CONTROL

PURPOSE:

This document outlines the efforts to be made to ensure that pests are controlled in all operational units.

Code: PLC 004

Price: CAD: 12.00

SANITATION: APPROVAL OF DISINFECTANTS MATERIALS

PURPOSE:

This practice establishes the minimum requirements for the approval of disinfectants used within the corporate manufacturing areas, and lists all approved disinfectants for product contact or incidental product contact use.

Code: PLC 006

Price: CAD: 30.00

MICROBIAL TESTING OF SURFACES

PURPOSE:

The purpose of this procedure is to provide the corporate operating units with a description of the method for microbial testing of surfaces

Code: PLC 008

Price: CAD: 25.00

PLANT SEPARATION OF OPERATIONAL AREAS

PURPOSE:

The purpose of this procedure is to describe the process for separating manufacturing and packaging operations from non-operational areas

Code: PLC 012

Price: CAD: 12.00

STORAGE AND HANDLING OF RECEIVED MATERIALS

PURPOSE:

The purpose of this document is to describe the Quality Assurance requirements to assure appropriate storage and special handling of raw ingredients, health products, and other materials

Code: PLC 014

Price: CAD 12.00

WATER SYSTEM AND QUALITY

PURPOSE:

This document provides guidance on the essential requirements for water system and quality used in health products manufacturing as a product component or in processing steps.

Code: PLC 020

Price: CAD 60.00

STANDARD OPERATING PROCEDURES (SOPs) ON EQUIPMENTS

EQUIPMENT QUALIFICATION

PURPOSE:

The purpose of this policy is to describe to the corporate manufacturing personnel the equipment qualification requirements, as specified in the International Conference on Harmonization ICH Guideline; “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”

Code: EQP 004

Price: CAD 70.00

EQUIPMENT VALIDATION

PURPOSE:

The purpose of this document is to provide corporate manufacturing sites with the necessary information on equipments validation requirements for sterile and non-sterile dosage forms. Utilization of this information should facilitate compliance with current GMPs

Code: EQP 006

Price: CAD 60.00

EQUIPMENT CLEANING VALIDATION POLICY

PURPOSE:

The purpose of this document is to describe the corporate equipment cleaning requirements and to provide guidance to ensure that equipment cleaning validation is effective and performed according to written operating procedures (for the cleaning of product contact equipment).

Code: EQP 008

Price: CAD 55.00

EQUIPMENT CLEANING: ACCEPTANCE CRITERIA CALCULATION

PURPOSE:

The purpose of this procedure is to provide corporate QA person with the equation to calculate the Residual Cleaning Limit (RCL), based upon the next product to follow, for products manufactured in dedicated equipment

Code: EQP 010

Price: CAD 20.00

EQUIPMENTS CLEANING AND SANITIZING PROCEDURE

PURPOSE:

The purpose of this document is to establish the system (procedure) to clean and sanitize the corporate production equipments

Code: EQP 018

Price: CAD 20.00

STANDARD OPERATING PROCEDURES ON PRODUCTION&PROCESS CONTROL

INCOMING MATERIAL SPECIFICATION REQUIREMENTS

PURPOSE:

This document outlines the incoming materials specifications and acceptance criteria.

Code: OPR 030

Price: CAD 20.00

SAMPLING OF RECEIVED MATERIALS

PURPOSE:

The purpose of this policy is to establish the requirements for the sampling of purchased chemicals, intermediates, and raw ingredients

Code: OPR 034

Price: CAD 20.00

CERTIFICATES OF ANALYSIS (COA)

PURPOSE:

This document is to describe the procedure for obtaining a complete Certificate of Analysis (COA) from suppliers, and to establish the responsibilities for transmitting and maintaining the record for raw incoming material and finished products

Code: OPR 038

Price: CAD 12.00

FINISHED PRODUCTS SPECIFICATIONS (NHP: HC)

PURPOSE:

The objectives of this document are (1) to establish standards for the identity, purity, quantity and potency and tolerances of finished Natural Health Products. (2) To describe tests, test methods (analytical and biological), and acceptance criteria, ranges or other criteria for the tests described. And (3) to establish the parameters to which finished products must conform to be acceptable for their intended use.

Code: OPR 042

Price: CAD 50.00

FINISHED PRODUCTS TRACKING NUMBER

PURPOSE:

The purpose of this procedure is to describe the process for identifying each lot of finished products with a distinctive tracking number / lot number.

Code: OPR 046

Price: CAD 10.00

MANUFACTURING PROCESSES: POWDER FORMULA

PURPOSE:

This document is to outline the processing (drying, filling and packaging) of powder formulas

Code: OPR 050

Price: CAD 12.00

NON-CONFORMING FINISHED PRODUCT CONTROL

PURPOSE:

This policy is to control non-conforming finished product and to initiate timely corrective action to correct the cause (s) of non-conformance.

Code: OPR 054

Price: CAD 17.00

FINISHED PRODUCTS TESTING AND RELEASE

PURPOSE:

The purpose of this document is to describe the procedures, which require to be conducted on imported or manufactured finished product, before being released for sale. This is to ensure the quality (identity, purity and quantity) of finished products.

Code: OPR 058

Price: CAD 25.00

THIRD PARTY LABORATORY TESTING

PURPOSE:

The purpose of this document is to establish the requirements and responsibilities for the use of third party laboratory testing

Code: : OPR 062

Price: CAD 20.00

STABILITY TESTING

PURPOSE:

The purpose of this policy is to define the stability data requirements to ascertain the normal shelf life of the products. Namely to determine how long the products can be expected to remain within specifications under recommended storage conditions and/or label claim.

Code: OPR 066

Price: CAD 50.00

SAMPLE RETENTION

PURPOSE:

The purpose of this policy is to describe the Quality Assurance requirements to ensure appropriate storage and managing of retained products.

Code: OPR 072

Price: CAD 12.00

STANDARD OPERATING PROCEDURES (SOPs) ON PRODUCT COMPLAINTS

PRODUCT COMPLAINT

PURPOSE:

The purpose of this policy is to describe the product complaint reporting requirements and responsibilities.

Code: OPR 080

Price: CAD 25.00

PRODUCT RECALL

PURPOSE:

The purpose of this SOP is to describe the processes for correction, withdrawal, or recall of finished marketed product for quality-related reasons, and to provide information on the recall reporting procedure.

Code: OPR 084

Price: CAD 30.00

QUALITY ASSURANCE AND AUDIT CHECKLIST

QUALITY ASSURANCE POLICY

PURPOSE:

To define the requirements, responsibilities, and procedures for Quality Assurance ( AA) compliance audits and to ensue that periodic and planned audits of systems and documentation shall meet regulatory bodies and corporate requirements for Good Manufacturing Practices. This document describes, also the usual governmental inspection practices and recommends specific methods and standards for responding to such inspectional activities.
In addition, this policy provides the framework for corporate Quality Management Documentation (QMD).

Code: OPR 090

Price: CAD 120.00

GOOD DOCUMENTATIONS PRACTICES GUIDELINE

PURPOSE:

This guideline provides the framework for documentation management. The framework includes document development process, document values, property, categories, types, and document templates.
(This is a part of the ”QUALITY ASSURANCE POLICY” document. Therefore, client might wish to purchase one of these, but not both documents)

Code: OPR 092

Price: CAD 55.00

INTERNAL AUDIT CHECKLIST FOR DRUG-PRODUCING FACILITIES

PURPOSE:

The purpose of this procedure is to establish the tool for self inspection (Internal audit) requirements in accordance with Health Canada; Drugs & Health Products Regulations (Good Manufacturing Practices Guidelines, 2002 Edition, Version 2).

Code: OPR 094

Price: CAD 300.00

INTERNAL AUDIT CHECKLIST FOR DIETARY SUPPLEMENTS-PRODUCING FACILITIES (US FDA parameters)

PURPOSE:

The purpose of this procedure is to establish the tool for self inspection (Internal audit) requirements in accordance with current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Final Rule, Food and Drug Administration, 21 CFR Part 111).

Code: OPR 096

Price: CAD 250.00

INTERNAL AUDIT CHECKLIST FOR NATURAL HEALTH PRODUCTS MANUFACTURING FACILITIES (HC parameters)

PURPOSE:

The purpose of this procedure is to establish the tool for self inspection (Internal audit) requirements in accordance with Health Canada; Natural Health Products Regulations (Good Manufacturing Practices, Part three, Sections 44 to 62).

Code: OPR 098

Price: CAD 200.00

CORRECTIVE AND PREVENTIVE ACTION (CAPA) POLICY

PURPOSE:

The purpose of this policy is to describe the approach to review quality system data to identify, correct, and prevent nonconformities.

Code: OPR 100

Price: CAD 20.00

STANDARD OPERATING PROCEDURES ON RECORDS & RECORDKEEPING

DOCUMENTS CREATION (SOP ON SOPs)

PURPOSE:

To describe the process for creating, updating, or revising the corporate policies, standard operating procedures (SOPs) and guidelines. All referred to collectively, herein, as "documents".

Code: OPR 110

Price: CAD 20.00

DOCUMENTS (SOPS & POLICIES): DISTRIBUTION AND CONTROL

PURPOSE:

The purpose of this document is to establish the system to control and manage the documents distribution among corporate employees. This is to assure that all key employees in the Regulatory Department read and understood the corporate procedures and policies.

Code: OPR 112

Price: CAD 25.00

RECORDS RETENTION AND DATA STORAGE

PURPOSE:

To establish the procedure to fulfill the regulatory authorities records retention requirements and to describe the process for storage of data by corporate headquarter.

Code: OPR 114

Price: CAD 12.00

PRODUCT MANUFACTURING: DOCUMENTATIONS REQUIREMENTS

PURPOSE:

This document is to establish documentation requirements for manufacturing of Natural Health Products and dietary supplementations.

Code: OPR 116

Price: CAD 15.00

COMMUNICATION WITH REGULATORY AUTHORITIES

PURPOSE:

To define the requirements for reporting and retaining information compiled from communications with local regulatory authorities.

Code: OPR 118

Price: CAD 12.00

MANAGING INFORMATION REQUEST AND DEFICIENCY NOTICE

PURPOSE:

To specify the process for managing information request and deficiency notices from local regulatory authorities.

Code: OPR 120

Price: CAD 12.00

STANDARD OPERATING PROCEDURES ON PACKAGING & LABELLING OPERATIONS

PRINTED MATERIALS (LABEL): DEVELOPMENT

PURPOSE:

To describe the process for preparing, and developing product label and all other printed supplies.

Code: OPR 130

Price: CAD 17.00

PRINTED MATERIALS: REVIEW AND APPROVAL

PURPOSE:

This SOP is to describe the process for reviewing and approving the corporate printed/promotional material (s).

Code: OPR 132

Price: CAD 12.00

PRINTED MATERIALS CONTROL

PURPOSE:

To assure that only current and accurate approved copy is ordered by the manufacturing plants.

Code: OPR 134

Price: CAD 12.00

RETURNED HEALTH PRODUCTS

RETURN AND DESTRUCTION OF HEALTH PRODUCTS SUPPLIES

PURPOSE:

This document is to provide the corporate with the necessary methodology and arrangements for returning and destruction of health products supplies.

Code: OPR 140

Price: CAD 17.00

CATEGORY TWO

STANDARD OPERATING PROCEDURES (SOPs) ON GOOD CLINICAL PRACTICES (GCPs)

CLINICAL TRIALS: PRINCIPLES

PURPOSE:

To provide the principles for conducting clinical investigations involving human subjects.

Code: CLN 001 Price: CAD 35.00

POST-MARKETING STUDIES

PURPOSE:

The purpose of this SOP is to give guidance on conducing post-marketing surveillance studies (PMS).

Code: CLN 002 Price: CAD 35.00

CONTRACT RESEARCH ORGANIZATION

PURPOSE:

This is to specify the procedure for transferring the corporate responsibilities, pertaining to clinical trials activities from the corporate to a second party (a Contract Research Organization).

Code: CLN 003 Price: CAD 35.00

PRE-TRIAL DOCUMENTATION

PURPOSE:

To describe the documentation required from the principle investigator prior to release of clinical product to start the clinical phase of the trial.

Code: CLN 004 Price: CAD 20.00

INVESTIGATOR SELECTION

PURPOSE:

To describe the process for selecting the investigators to conduct clinical trials involving human subjects.

Code: CLN 005 Price: CAD 15.00

CLINICAL TRIALS: SPONSOR RESPONSIBILITIES

PURPOSE:

To define the corporate responsibilities as a sponsor for conducting clinical trials under ICH: GCP Guideline.

Code: CLN 006 Price: CAD 80.00

CLINICAL TRIALS: INVESTIGATOR RESPONSIBILITIES

PURPOSE:

To define the responsibilities of the investigator who is involved in clinical research involving human subjects.

Code: CLN 007 Price: CAD 70.00

CLINICAL TRIALS: CONFIDENTIALITY AGREEMENT

PURPOSE:

This SOP is to provide a protection of information proprietary to the corporate.

Code: CLN 008 Price: CAD 25.00

RESEARCH ETHICS BOARD REVIEW AND APPROVAL

PURPOSE:

To define the function of the Research Ethics Board (REB) in clinical trials, and to define the relationship among the corporate, the investigator and the REB.

Code: CLN 009 Price: CAD 40.00

INFORMED CONSENT FORM

PURPOSE:

To provide the essential requirements for writing an informed consent form.

Code: CLN 010 Price: CAD 70.00

CLINICAL CASE REPORT

PURPOSE:

To provide instructions to corporate Clinical Research Associates (and other clinical project team members) on managing and handling clinical case reports.

Code: CLN 011 Price: CAD 45.00

SITE MASTER FILE

PURPOSE:

To define the documents required to be established and maintained by the clinical investigator before, during, and after the completion or discontinuation of a clinical trial.

Code: CLN 012 Price: CAD 50.00

CLINICAL TRIAL MASTER FILE

PURPOSE:

To define the documents that must be retained in the clinical trial master file.

Code: CLN 013 Price: CAD 45.00

CLINICAL SUPPLY ACCOUNTABILITY

PURPOSE:

To define the accountability requirements for clinical supplies including randomization envelopes and blind breaker envelopes.

Code: CLN 014 Price: CAD 50.00

INVESTIGATIONAL PRODUCT ADVERSE EVENT

PURPOSE:

This document is to describe the procedure for reporting clinical trials adverse events.

Code: CLN 015 Price: CAD 40.00

MANUFACTURING OF CLINICAL SUPPLY

PURPOSE:

To provide the procedure for the preparation (manufacturing) of clinical supplies for clinical trials in human subjects.

Code: CLN 016 Price: CAD 25.00

PREPARATION OF CLINICAL TRIALS LABEL

PURPOSE:

To describe the process for preparing, and approving clinical trial labels & other printed supplies.

Code: CLN 017 Price: CAD 30.00

SHIPMENT OF CLINICAL SUPPLY

PURPOSE:

To provide the procedure for handling (shipping) of clinical supplies for clinical trials.

Code: CLN 018 Price: CAD 45.00

INVESTIGATIONAL PRODUCT RECALL

PURPOSE:

The purpose of this SOP is to describe the processes for withdrawal, correction or recall of investigational product supplies.

Code: CLN 019 Price: CAD 35.00

RETURN AND DESTRUCTION OF CLINICAL SUPPLIES

PURPOSE:

To provide the procedures for returning and destruction of clinical trials product supplies.

Code: CLN 020 Price: CAD 30.00

MANAGEMENT OF EXPIRED AND EXTENDED INVESTIGATIONAL SUPPLY

PURPOSE:

To describe the process and responsibilities for managing expired investigational product and updating product labels with retest/expiry dating at an investigational site.

Code: CLN 022 Price: CAD 15.00

CLINICAL TRIAL TRAINING REQUIREMENTS

PURPOSE:

To describe the requirements for clinical trials training, and the procedures for conduct and document of clinical training.

Code: CLN 023 Price: CAD 60.00

DECLARATION OF HELSINKI’ TEXT

PURPOSE:

To distribute the latest version of Declaration of Helsinki, to all corporate clinical research employees.

Code: CLN 024 Price: CAD 10.00

CLINICAL TRIALS REGULATORY REQUIREMENTS

PURPOSE:

To describe the regulatory authorities requirements for conducting clinical investigations, involving human subjects.

Code: CLN 025 Price: CAD 10.00

TRANSPORTATION OF BLOOD AND BLOOD COMPONENTS

PURPOSE:

The purpose of this procedure is to describe the procedure for the safe transportation of blood and blood components.

Code: CLN 030 Price: CAD 50.00

CLINICAL TRIAL AUDIT

PURPOSE:

To define the procedure for clinical investigator site auditing.

Code: CLN 040 Price: CAD 50.00

CLINICAL TRIALS: ESSENTIAL DOCUMENTS CHECKLIST (ICH PARAMETERS)

PURPOSE:

To provide the corporate/CRO clinical research associate with a guidance on clinical trials required documentations during the planning stage, during the trial, and after completion or termination of the trial as per the ICH Good Clinical Practices: Consolidated Guideline.

Code: CLN 041 Price: CAD 40.00

CONTRACT RESEARCH ORGANIZATION (CRO) CAPABILITIES CHECKLIST (Section One)

PURPOSE:

To provide the corporate medical department with a tool to evaluate the Contract Research Organization capabilities to conduct clinical trials on human subjects. This checklist could be used also by a third party auditor on behalf of the corporate.

Code: CLN 042 Price: CAD 70.00

CONTRACT RESEARCH ORGANIZATION (CRO)

PURPOSE:

To provide the corporate medical department with a tool to evaluate the investigational site capabilities checklist (section two) to conduct clinical trials on human subjects. This checklist could be used also by a third party auditor on behalf of the corporate.

Code: CLN 043 Price: CAD 45.00

CLINICAL LABORATORY EVALUATION CHECKLIST (Section Three)

PURPOSE: :
To provide the corporate medical department with a tool to evaluate the clinical laboratory capabilities to perform tests and examinations on all tests specified in the study protocol. This checklist could be used also by a third party auditor on behalf of the corporate.

Code: CLN 044 Price: CAD 35.00

CONTRACT RESEARCH ORGANIZATION (CRO) EVALUATION CHECKLIST (The three sections CLN 042, CLN 043, And CLN 044 combined).

PURPOSE:

To provide the corporate medical department with a tool to evaluate the proposed contract research organization and associated institutions (the investigational site and clinical laboratory capabilities) to conduct clinical trials on human subjects. This checklist could be used also by a third party auditor on behalf of the corporate to evaluate the Contract Research Organization capabilities.

Code: CLN 045 Price: CAD 120.00

DELIVERY OPTIONS:

Please note that:

The indicated prices are in Canadian Dollar and based on delivering the document via email.

Orders will be mailed within three business days from receipt of the payment. Therefore, when estimated delivery time will be calculated, please take in consideration that we will only be counting regular business days excluding Saturday and Sunday.

Extra charges will be added if you choose to receive the document as a hard copy, or by a CD.

Shipping charges for Canada, US and overseas will be calculated according to available carriers average current Canada Rates.