Name
Street
City
State
Zip
E-mail
Phone #	--
Fax #	--
Type of Study Required
Type of Product Under Development
Number of Patients
Number of Centers (if known)
Duration of Study
Name of Product (optional)

A. DOCUMENT DEVELOPMENT

1. Consult on study design

Sponsor CRDS

2. Write protocol & model informed consent

Sponsor CRDS

3. Design Case Report Forms

Sponsor CRDS

4. Print CRF

Sponsor CRDS

5. Supply patient diary cards

Sponsor CRDS

6. Supply patient instructions

Sponsor CRDS

7. Ship CRFs, manuals & diary cards

Sponsor CRDS

B. CLINICAL SUPPLIES

1. Supply placebo drug

Sponsor CRDS

2. Supply package & labeled test agent

Sponsor CRDS

3. Ancillary clinical supplies

Sponsor CRDS

4. Storage during study

Sponsor CRDS

5. Track Inventory

Sponsor CRDS

6. Ordering, handling, and delivering to sites

Sponsor CRDS

7. Supply randomization codes

Sponsor CRDS

8. Supply drug logs

Sponsor CRDS

9. Ship clinical supplies

Sponsor CRDS

10. Return of all unused materials to sponsor

Sponsor CRDS

C. SITE IDENTIFICATION AND INITIATION

1. Identification of potential Investigators

Sponsor CRDS

2. Conduct site evaluation visits and provide reports

Sponsor CRDS<

3. Select investigators/finalize list

Sponsor CRDS

4. IRB submission

Sponsor CRDS

5. Study initiation visits

Sponsor CRDS

6. Train site personnel

Sponsor CRDS

7. Collection of clinical site regulatory documents

Sponsor CRDS

8. Submit site registration documents to sponsor

Sponsor CRDS

8. Investigator Grant Negotiation

Sponsor CRDS

D. MONITORING SERVICES

1. Conduct on-site monitoring visits every ten patients and provide written reports to sponsor

Sponsor CRDS

2. Check and verify 100% of CRFs against source documents

Sponsor CRDS

3. Maintain telephone contacts with study sites

Sponsor CRDS

4. Perform test agent accountability audits each monitor visit

Sponsor CRDS

5. Clinical site regulatory documents

Sponsor CRDS

6. Supervise correction of CRFs at study sites

Sponsor CRDS

7. Telephone reports

Sponsor CRDS

8. Monitoring reports

Sponsor CRDS

9. Handle protocol amendments

Sponsor CRDS

10. Complete study close-out visit at each site

Sponsor CRDS

11. Data Review

Sponsor CRDS

12. Investigator Grant Management

Sponsor CRDS

E. ADVERSE EVENT REPORTING

1. Gather information for sponsor

Sponsor CRDS

2. Provide written information & follow up

Sponsor CRDS

3. Provide medical judgment

Sponsor CRDS

4. Submit to Sponsor

Sponsor CRDS

5. FDA notification

Sponsor CRDS

F. DATA MANAGEMENT SERVICES

1. Develop data review rules

Sponsor CRDS

2. In-house QC review of CRFs

Sponsor CRDS

3. Develop coding of data items

Sponsor CRDS

4. Database development (SAS)

Sponsor CRDS

5. Design Database/data entry screens

Sponsor CRDS

6. Clean up CRFs

Sponsor CRDS

7. Enter CRFs into database

Sponsor CRDS

8. Double key punch data entry

Sponsor CRDS

9. Data listings (generation, review, transmittal to sponsor)

Sponsor CRDS

10. Automated data check programs

Sponsor CRDS

11. Investigation and resolution of data discrepancies

Sponsor CRDS

12. 10% QC database audit

Sponsor CRDS

13. CRF tracking (final CRFs to Sponsor)

Sponsor CRDS

14. Transfer database to Sponsor

Sponsor CRDS

15. Study Documentation

Sponsor CRDS

G. BIOSTATISTICS

1. Biostatistical consultation

Sponsor CRDS

2. Protocol development

Sponsor CRDS

3. CRF review

Sponsor CRDS

4. Statistical method section development

Sponsor CRDS

5. Sample size estimation

Sponsor CRDS

6. Randomization

Sponsor CRDS

7. Statistical Analysis

Sponsor CRDS

8. Statistical Report

Sponsor CRDS

H. CLINICAL REPORTING SERVICES

1. Full integrated clinical/statistical report

Sponsor CRDS

2. Regulatory Consulting/Submissions

Sponsor CRDS