Request for Proposal

CRO Industry Request for Proposal

At PMI, we look forward to working with you to make your next clinical study a success. If you would like to request an estimate for a project, please download and sign our standard Confidentiality Agreement (PDF). Mail or fax this document to our corporate headquarters:

Promedica International
3070 Bristol Street, Suite 530
Costa Mesa, CA 92626
Fax: 714.460.7364

Once we have received the Confidentiality Agreement, you’ll be asked to complete the Request for Proposal (PDF) which provides us with the information necessary for developing our estimate.

If you have any questions about the RFP process or about PMI, please call us at 714.460.7363.

Service Proposal Worksheet

General Information
Name
First Last
Title or Dept:
Company Name:
Telephone:
Address 1:
Fax:
Address 2:
Email Address:
Enter Email Confirm Email
City, State:
Website
Country, Zip Code:
Project Description
(Include study product indication for use)
Study Product Type
- Device
- Pharmaceutical
- Biologic
U.S. Regulatory Status of Product
- Investigational
- Cleared by FDA for U.S. Marketing
Reason for Request
- Proposal for funding
- Competitive CRO assessment
By what date would you prefer to have our proposal?
Study Information
(Please provide requested information below, or forward study protocol outline in Case Report Forms)
1. What is the total number of study subjects (test & control)?
2. What is the total number of US study sites?
3. What is the total number of study sites outside US?
3a. Location(s):
4. What is the total number of core laboratories/reading centers?
5. What is the number of laboratories at each site?
6. When is the anticipated date for study initiation?
7. How long will it take to enroll all subjects?
8. How many interim analyses are planned?
Study Information Continued
(Please list ALL study exams below, unless ALL CDFs are provided with this submission)
Study Visit When Visit Occurs # CRF Pages for Visit
(Please provide the following information regarding study monitoring plans, if applicable)
1. Number of pre-study visits/site
2. Number of study initiation visits/site
3. Number of interim monitoring visits/site
4. Percentage of subjects for whom all data will be source verified
5. Number of core laboratory/reading center monitoring visits
6. Number of close-out visits/site
Services Desired
(Please indicate below the services you would like to have included in our proposal)
Clinical Study Site Management & Monitoring
- Site recruitment
- Site qualification
- Site budget development
- Site contract negotiations
- IRB/Ethics Committee submission coordination
- Site training program development
- Investigator meeting
- Study participation recruitment program development
- Study initiation visits
- Interim study monitoring visits
- Maintenance of essential regulatory documents
- SAE/UADE initial contact & follow-up
- Site/subject payment administration
- Study product inventory management
- Study close-out visits
Other
Clinical Study Data Management/Biostatistics
- CRF development
- Database development
- Data entry & verification
- Query generation & resolution
- AE coding
- Data QC
- Subject randomization plan development
- Statistical analysis
Other
Medical Writing
- Protocol development
- Clinical Investigator Brochure development
- Clinical study report(s) development
Other
GCP Compliance
- Study audit
- SOP development
- GCP training
- Assistance with FDA site inspection
Other
Regulatory Affairs
- Coordinate IDE/IND application
- Coordinate 510(k) application
- Coordinate PMA application
- Coordinate NDA application
- Establishment registration
- Product listing
- Assistance with FDA site inspection
Other
Other Services Desired
(please specify below)
Comments
This field is for validation purposes and should be left unchanged.

Study Visit	When Visit Occurs	# CRF Pages for Visit

CRO Industry Request for Proposal

Service Proposal Worksheet

General Information

Project Description

Study Information

Services Desired