Clinical Trials Application

Submission of this information does not represent a binding of any insurance contract or agreement. Additional information may be required in order to get an accurate quote of insurance.

"*" indicates required fields

LOCATIONS & OPERATIONS

Additional Locations

Address

City

Province

Postal Code

Subsidiaries or Related Companies

Company Name

Description of Operations

Relationship to Applicant

Please describe your business operations*

Describe: Products, Services, Research activities, Manufacturing, Distribution, Consulting

REVENUE

Revenue by Activity

Last 12 Months

Next 12 Months

Geographic Revenue

Canada

Canada Previous Revenue

Canada Forecast Revenue

USA

USA Previous Revenue

USA Forecast Revenue

Rest of World

Rest of World Previous Revenue

Rest of World Forecast Revenue

Countries where products are sold outside Canada and USA

Do you Preform Clinical Trials?*

Yes

CLINICAL TRIAL DETAILS

Current Clinical Trials

Product / Protocol Name & Number

Phase

No. of Subjects Current

No. of Subjects Total

Country

Disease / Indication Being Tested

Trial Status

Revenue (If Any)

Are all clinical trials registered with and conducted in accordance with the appropriate government authorities?

Yes

Are all clinical trials approved by the applicable Ethics Committee / Research Ethics Board?

Yes

Are all clinical trials conducted in accordance with ICH (International Council for Harmonisation) Guidelines?

Yes

Does your organization recruit its own study participants?

Yes

Do all participants provide informed consent before taking part in a trial?

Yes

Does your organization provide medical advice or operate an inpatient facility as part of any clinical trial?

Yes

Have any Adverse Event Reports been filed relating to your products within the past 5 years?

Yes

Please provide details

Did any adverse event involve

Death

Hospitalization

Permanent Injury

How many Expanded Access / Compassionate Use participants are currently involved?

Have any Clinical Investigators associated with your organization been cited for regulatory violations?

Yes

Please provide details

Do any of your clinical trials involve any of the following?

Does your organization assume liability for the product under contract?

Yes

Do your contracts contain Hold Harmless agreements in favour of your organization?

Yes

Were any of the clinical trial protocols written by one of your employees or physicians practicing at your facility?

Yes

Is the presiding physician a member of the CMPA?

Yes

Additional Information

Please provide any additional information that may assist in underwriting your application.

FACILITIES & LABORATORIES

Do you operate laboratory facilities?*

Yes

Biohazard Laboratory Rating*

Do you store hazardous materials?*

Yes

Describe materials stored*

Are hazardous materials handled and disposed of in accordance with applicable regulations?*

Yes

Do you have laboratory animals on-site?*

Yes

Do you have property belonging to others in your care, custody or control?*

Yes

Please describe*

Examples: Samples, Research materials, Equipment, Inventory

PRODUCT & REVENUE BREAKDOWN

If applicable, please indicate the approximate percentage (%) of gross revenue attributable to each product category. Total should equal 100%.

Product Category % of Gross Revenue

Blood and Blood Components

Please enter a number from 0 to 100.

Components, Fine Chemicals & APIs

Please enter a number from 0 to 100.

Controlled Drugs

Please enter a number from 0 to 100.

Cosmetics

Please enter a number from 0 to 100.

Dietary Supplements & Vitamins

Please enter a number from 0 to 100.

Drug Delivery Products

Please enter a number from 0 to 100.

Generic Biologics

Please enter a number from 0 to 100.

Generic Pharmaceuticals

Please enter a number from 0 to 100.

Imaging & Diagnostic Agents

Please enter a number from 0 to 100.

Infusions

Please enter a number from 0 to 100.

Nutraceuticals & Natural Health Products

Please enter a number from 0 to 100.

Over-the-Counter Biologics

Please enter a number from 0 to 100.

Over-the-Counter Pharmaceuticals

Please enter a number from 0 to 100.

Proprietary Biologics

Please enter a number from 0 to 100.

Proprietary Pharmaceuticals

Please enter a number from 0 to 100.

Radiopharmaceuticals

Please enter a number from 0 to 100.

Vaccines

Please enter a number from 0 to 100.

Veterinary Products

Please enter a number from 0 to 100.

Other (please specify)

Please enter a number from 0 to 100.

Description of Other Products:

Total Revenue Allocation:*

(should equal 100%)

PHARMACEUTICAL & BIOLOGIC PRODUCT BREAKDOWN

Complete this section only if your operations involve pharmaceutical or biologic products. Please indicate the approximate percentage (%) of pharmaceutical and biologic revenue attributable to each therapeutic category. Total should equal 100%.

Therapeutic Category % of Pharmaceutical / Biologic Revenue

Alimentary Tract & Metabolism

Please enter a number from 0 to 100.

Anti-Infectives for Systemic Use

Please enter a number from 0 to 100.

Antineoplastic & Immunomodulating Agents

Please enter a number from 0 to 100.

Antiparasitic Products, Insecticides & Repellents

Please enter a number from 0 to 100.

Blood & Blood-Forming Organs

Please enter a number from 0 to 100.

Cardiovascular System

Please enter a number from 0 to 100.

Dermatologicals

Please enter a number from 0 to 100.

Genito-Urinary System & Sex Hormones

Please enter a number from 0 to 100.

Musculo-Skeletal System

Please enter a number from 0 to 100.

Nervous System

Please enter a number from 0 to 100.

Respiratory System

Please enter a number from 0 to 100.

Sensory Organs

Please enter a number from 0 to 100.

Systemic Hormonal Preparations

Please enter a number from 0 to 100.

Other (please specify)

Please enter a number from 0 to 100.

Description of Other Therapeutic Category:

Total Therapeutic Allocation:*

(should equal 100%)

Have any products been on the market less than 3 years?

Yes

Product Details

Have any products been recalled or withdrawn within the last 5 years?

Yes

Recall Details

Have there been any adverse event reports involving your products within the last 5 years?

yes

Adverse Event Details

Did any adverse event involve death, hospitalization, or permanent injury?

Do any products contain significant warnings, boxed warnings, or similar safety advisories?

Yes

Details

Are any products sold under third-party brands or incorporated into another company's products?

Yes

Details

Are all products approved by applicable regulatory authorities?

Yes

Do you expect to launch any new products within the next 12 months?

Yes

Details

Do you provide any clinical services?

Yes

Details

Do employees interact directly with patients, consumers, or end users?

Yes

Details

RESTRICTED, SPECIALTY OR HIGH-RISK PRODUCTS

Are you involved in the manufacture, importation, distribution, sale, supply, research, testing, labelling, repackaging, or use of any of the following products or their derivatives? Please note that some of the products below may be excluded in the insurance policy, but coverage may be extended in some circumstances

Yes

If Yes, please select all that apply:

Please provide details of any selected products, including their intended use, annual revenue, and regulatory approval status:

REGULATORY & QUALITY CONTROL

Are you in compliance with all applicable regulatory requirements and guidelines?

Yes

Have you been cited for any regulatory violations within the past 5 years?

Yes

Please provide details

Do you follow Good Manufacturing Practices (GMP)?

Yes

Not Applicable

Are you ISO registered or certified?

Yes

ISO Standard:

ISO Number / Certification Number:

For how many years do you maintain batch samples of your products?

Do you conduct regular batch testing of your products?

Yes

Not Applicable

Do you maintain a formal Product Recall Procedure?

Yes

Do you maintain a formal written Quality Control (QC) and/or Quality Assurance (QA) program?

Yes

Do you maintain rights of recourse against your suppliers and/or product manufacturers?

Yes

Not Applicable

Do you maintain a formal Risk Management and Loss Prevention Program?

Yes

Please provide your current Pharmaceutical Product Establishment Licence (if applicable):

Date of most recent Health Canada inspection (if applicable):

Do you maintain procedures for documenting incident reports, complaints, adverse events, or product concerns?

Yes

Do you obtain certificates of insurance from suppliers and contractors?

Yes

Not Applicable

Are contracts reviewed by legal counsel or your legal representative?

Yes

Do you review policies and procedures on a regular and ongoing basis?

Yes

CLAIMS HISTORY

Any insurance claims in the last 5 years?

Yes

Any insurance claims in the last 5 years? yes

Date

Description

Amount Paid

Status

Any incidents that could lead to a future claim?

Yes

Details

PRIOR INSURANCE

Has insurance ever been:

Declined

Cancelled

Non-Renewed

None

Details

Requested Insurance Coverage

1. Commercial General Liability & Product Liability*

$2M

$5M

$10M

Provides coverage for eligible claims alleging bodily injury or property damage arising from your business operations and products, subject to the policy’s terms, conditions, and exclusions.

2. Errors & Omissions / Professional Liability*

$2M

$5M

$10M

Provides protection for claims alleging financial loss resulting from professional services, advice, research, consulting, testing, design, or other professional activities performed by your organization. Coverage is subject to policy terms, conditions, exclusions, and any retroactive date requirements.

3. Medical Malpractice / Professional Healthcare Liability*

$2M

$5M

$10M

May provide protection for claims arising from healthcare, clinical, medical, scientific, laboratory, or related professional services provided by qualified personnel. Coverage availability depends on the nature of services provided and underwriting approval.

4. Clinical Trials Liability (Optional)

Not Required

$2M

$5M

$10M

May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.

5. Product Recall Expense (Optional)

Not Required

May help reimburse certain expenses associated with the withdrawal, recall, replacement, inspection, communication, or disposal of products when a covered recall event occurs. Coverage varies significantly by insurer and policy wording

6. Cyber Liability (Optional)

Not Required

$2M

$5M

$10M

May provide protection for certain costs and liabilities arising from data breaches, privacy incidents, ransomware events, network security failures, or cyber-related business interruptions. Coverage varies by insurer and policy wording.

7. Property Insurance (Optional)

Not Required

May provide coverage for buildings, tenant improvements, equipment, inventory, laboratory contents, and other insured property against specified causes of loss. Coverage is subject to policy terms, valuation provisions, exclusions, and deductibles.

8. Equipment Breakdown (Optional)

Not Required

May provide coverage for sudden and accidental mechanical or electrical breakdown of eligible equipment, including certain laboratory, manufacturing, refrigeration, and production equipment. Coverage is subject to policy conditions and exclusions.

9. Crime Coverage (Optional)

Not Required

May provide protection for certain losses resulting from employee dishonesty, theft, fraud, forgery, funds transfer fraud, or other covered criminal acts. Coverage varies by policy and insurer.

10. Directors & Officers Liability (Optional)

Not Required

$2M

$5M

$10M

Provides protection for claims alleging wrongful acts committed by directors, officers, board members, or senior management while acting in their official capacity on behalf of the organization. Coverage is subject to policy terms, exclusions, and conditions.

11. Environmental / Pollution Liability (Optional)

Not Required

$2M

$5M

$10M

May provide protection for certain liabilities arising from pollution conditions, contamination events, cleanup costs, or environmental damage where coverage is specifically provided under the policy. Coverage is subject to underwriting review and policy wording.

ADDITIONAL COVERAGE INFORMATION

For any coverage requested above, please indicate any desired deductible(s), retroactive date(s), aggregate limit(s), or other coverage requirements not already specified.

Retroactive Date(s):

Have these coverages been maintained continuously from the retroactive date(s) indicated above?

Yes

Please provide details

Clinical Trials Application

COMPANY INFORMATION

LOCATIONS & OPERATIONS

REVENUE

CLINICAL TRIAL DETAILS

FACILITIES & LABORATORIES

PRODUCT & REVENUE BREAKDOWN

PHARMACEUTICAL & BIOLOGIC PRODUCT BREAKDOWN

RESTRICTED, SPECIALTY OR HIGH-RISK PRODUCTS

REGULATORY & QUALITY CONTROL

CLAIMS HISTORY

PRIOR INSURANCE

Requested Insurance Coverage

ADDITIONAL COVERAGE INFORMATION

Toronto

Mississauga