| Company Profile |
|
|
| *Name of Company: |
|
|
| *Type of Business: |
|
Check all that apply:
Nutraceutical / Natural Medicine
Pharmaceutical
Biotechnology
Academic / University
Others (Please Specify):
|
| *Your Name: |
|
|
| *Your Position: |
|
|
| *Your Address: |
|
|
| *Phone Number: |
|
|
| *Fax Number: |
|
|
| *Email Address: |
|
|
|
|
|
|
|
|
| Product Information |
|
|
| Name of Product: |
|
|
| Active Ingredient(s): |
|
|
| Nature of Product: |
|
Nutraceutical/Dietary Supplement/Herbal
Medical Food
OTC Healthcare
Drug
Others (Please Specify):
|
| Form of Product: |
|
Oral - Pill
Oral - Powder
Oral - Liquid
Topical
IV - Intravenous
IM - Intramuscular
SC - Subcutaneous
Others (Please Specify):
|
| Product Indications: |
|
|
| Usage Instructions: |
|
|
|
|
|
|
| What is the main reason for having this product tested? |
|
Check all that apply:
Product Research and Development
Claim Substantiation and Regulatory Compliance
Marketing and Business Development Material
Others (Please Specify):
|
| What is your primary objective in testing the product(s)? |
|
Check or provide only one primary essential objective:
Safety of the Product
Efficacy of the Product
Replication Study
Please define your primary objective: |
| What are your secondary objectives? |
|
|
| Note: If you did not attach a protocol synopsis or reference study, please share your thoughts on how you would like this study to be completed. |
|
|
|
|
|
|
|
|
| For Clinical Trials: |
|
|
| Subjects |
|
|
| What type of subject population are you trying to use this product for? |
|
Healthy Subjects
Subjects with certain disorders or conditions
Please specify: |
| Subject preferences; if any |
|
|
| Sex: |
|
|
| Age Range: |
|
|
| Ethnicity: |
|
|
| Number of Subjects Needed per Group; if known: |
|
|
| Study Design |
|
|
| Type of Study: |
|
Laboratory Analysis
Case Study
Pre-Clinical
RCT: Product compared to a placebo only
RCT: Product compared to a competitor only
RCT: Product compared to a placebo and competitor
RCT: Multiple Investigational Arms
|
| Competitor Reference: |
|
None
Brand Name (Please Specify):
|
| Assessments: Please list what you want to measure and known specific tests you would like to use to perform these measurements. |
|
|
| Mean and STDV: Please input Mean and Standard Deviations if known of the above listed assessment/measures. |
|
|
| Clinical Efficacy |
|
|
Please estimate the level of clinical meaningfulness your product is likely to have on the subject population
Note: Keep in mind the smaller the clinical meaningfulness, the more subjects needed. However be cautious not to overestimate clinical significance which could result in the study not having enough power to detect meaningful difference between the study product and placebo comparative.
|
|
Small
Medium
Large
|
|
|
|
| Additional Information |
|
|
| Company's average annual revenue over past 2 years (in US$): |
|
|
| Company's anticipated annual revenue for the next fiscal year (in US$): |
|
|
| For the product to be tested; average annual revenue over the past 2 years if applicable (in US$) |
|
|
| For the Product to be Tested; Anticipated Annual Revenue post completion of study (in US$) |
|
|
| Allotted budget for study (in US$): |
|
|
| Other Services of Interest: |
|
Assistance in Getting Funding
Assistance in Getting Clinical Trials
Assistance in Managing Our Clinical Research Site
Assistance in Getting Patients for Other Clinical Trial we are conducting
Others (Please Specify): |
Thank you for this information. We will contact you shortly to schedule a discussion to further explore your project(s). Thereafter, we will provide a preliminary proposal and cost analysis.
|
|
|
| If you have any questions - please do not hesitate to contact me at: |
|
|
Paul Ernest de Leon
Research and Development Manager
Product Research and Development Department
|
|
|
Exodon, LLC
111 Howard Boulevard
Mt. Arlington, New Jersey
USA, 07856 |
|
|
PN: (973) 398 2900 ext 4520
FN: (973) 710 9158
EA: PNDleon@exodon.com |
|
|
|
|
|
TO BE COMPLETED BY INVESTIGATOR ONLY
These questions need to be answered by the researcher/clinician only. Please circle your response.
|
|
|
| 1. After reviewing a study protocol, how much time do you think you will need to decide if you want to participate in a study?
|
|
1 Hour or Less
2-24 Hours
More than 1 Day
2 -3 Days
Greater than 4 days
|
| 2. What is your tolerance level for making decisions that might have large negative consequences? |
|
Very tolerant
Moderately tolerant
Not very tolerant
|
| 3. Do you prefer to be a Principal Investigator on studies? |
|
As often as possible
At least half of the time
Doesn't matter
|
| 4. How important is it for your site to be able to compete against other clinical research sites? |
|
Very Important
Moderately Important
Not very Important
|
| 5. How important is it to move beyond the status quo and develop a cutting edge clinical research practice? |
|
Very Important
Moderately Important
Not Very Important
|
| 6. When making decisions, how important is 'striking while the iron is hot'? |
|
Very Important
Moderately Important
Not Very Important
|
| 7. How would you rate your level of Persistence? |
|
Very Persistent
Moderately Persistent
Not Very Persistent
|
| 8. When making important decisions, how worried do you typically get? |
|
Very Worried
Moderately Worried
Not Very Worried
|
| 9. How absorbed do you become in a single clinical research study? |
|
Very absorbed
Moderately absorbed
Not very absorbed
|
| 10. When working on a research hypothesis how much do you value lively and spirited interaction from others? |
|
Very Much
Moderately
Not Very Much
|
| 11. When working on a research hypothesis how much do you value facts? |
|
Very Much
Moderately
Not Very Much
|
| 12. How important is saving money when conducting research? |
|
Very Important
Moderately Important
Not Very Important
|
|
|
|
| |
|
|
|
