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Questions & Answers About Being A Studycast Affiliate InvestigatorBelow are some of the questions frequently asked by investigational sites about being a Studycast Affiliate Investigator.
How does my site become a member? Becoming a Studycast member is simple. Complete the Studycast registration form in its entirety. We will review your registration application. If you meet all of our criteria, we will contact you regarding an on-site review. This process can take as little as a couple of weeks to as long as several months. Following a successful on-site review, we will enter into a formal written agreement with you and your site. Can my site conduct non-Studycast studies? Yes. As a Studycast Affiliate Investigator, your site's membership in Studycast can be non-exclusive. However, fees are higher for non-exclusive site. Additionally, all services and opportunities may not be available to non-exclusive sites. As a non-exclusive affiliate, your site retains the right to contract with any Sponsor at any time for any study that was not first presented to your site by Studycast. Note: Studycast has a web page for non-exclusive affiliates to document involvement with non-Studycast trials. ALL Sponsor contacts about trials must be recorded within 24 hours. If a non-exclusive affiliate is contacted by Studycast about a trial that has not been recorded, the non-exclusive affiliate can only participate on that trial through Studycast. Failure to adhere to this rule can result in cancellation of membership. Will the Sponsor contact my site directly? No. Studycast facilitates all initial contact between your site and the Sponsor. Studycast acts as your agent for participation in a Studycast trial. Will the Sponsor contract directly with my site? Yes. You will contract directly with the Sponsor for each Studycast study. Additionally, you will have a separate contract with Studycast for each Studycast study. Does Studycast charge my site a fee? Yes. Studycast charges an exclusive affiliate fee of 20% of the total study budget for all Studycast trials in which your site participates. For example, if the study budget is for 20 patients at $3,500 each (including overhead) with a total budget of $70,000, then our fee would be $14,000. The fee for non-exclusive affiliate sites is 25% of the total study budget. As your fiscal agent, Studycast bills Sponsors monthly for all activities performed by your site on a Studycast trial. The Onset fee payable to Studycast will be 5% of the total study budget deductible from your startup payment from the Sponsor (per the negotiated agreement for each trial) OR 50% of the startup payment from the Sponsor, whichever is higher. For exclusive affiliate sites, subsequent payments shall be deducted from monthly receipts from Sponsors at a rate of 15% (or less, adjusted by the percentage of total study budget paid to Studycast as an Onset fee) of total study budget divided by the total number of months projected for the study. For example, monthly payments on a 12-month study would equal 1.25% of total study budget. Any unpaid fees shall accrue in your site's account. The Guarantee Payment is 20% of the Minimum Enrollment Guarantee pro-rated portion of your site's total study budget. For example, if your total study budget is $70,000 for 20 patients and your Minimum Enrollment Guarantee is 12, then your Guarantee Payment is $8,400 ($70,000 x 12/20 x 20%). The Final Payment is deducted from the final receipts provided by the Sponsor for a Studycast trial. If the total number of subjects enrolled exceeds the study budget, the formula for the Final Payment still applies as it accounts for excess subjects. Your site must pay Studycast fees for any additional subjects. If the total number of subjects enrolled does not meet the Minimum Enrollment Guarantee, your site is not entitled to any refund of Studycast fees. Your site is liable to Studycast for the full amount of this Guarantee Payment. For non-exclusive affiliate sites, all fee payments are adjusted to represent the higher fee level. What are Minimum Enrollment Guarantees? Minimum Enrollment Guarantees are required for participation in Studycast trials. Your site's contract with the sponsor will guarantee a minimum enrollment. For example, you may agree to enroll 20 subjects into a study with a guarantee of 12 subjects. Your Minimum Enrollment Guarantee must be at least 60% of the total number of subjects for which you have contracted. Your Minimum Enrollment Guarantee is the assurance to the sponsor that you have carefully reviewed the protocol and are confident that you have the patient population as you will not receive a refund of your Studycast Guarantee Payment. We also refer to Minimum Enrollment Guarantees as your "dump" number. Your "dump" number is the number of subjects that you will be able to "dump" into the study within the first three weeks after your site has been initiated. What happens if my site fails to meet its Minimum Enrollment Guarantee? If your site fails to meet its Minimum Enrollment Guarantee, Studycast may, at its sole discretion, choose to cancel your site's Studycast membership. We may also place your site on probation and/or perform a remedial evaluation of your site. Because the Minimum Enrollment Guarantee is one of the primary criteria that Sponsors use in evaluating our service, it is critical that sites meet this requirement. Can my site's Studycast membership be cancelled? Yes. Your site's Studycast membership can be cancelled. Membership in Studycast is at-will and can be cancelled by Studycast, at its sole discretion, at any time. Cancellation of your site's Studycast membership does not release your site from any other financial, confidentiality, or other performance obligations to Studycast or any of its Sponsors. Your site's Studycast membership can be cancelled, at Studycast's sole discretion, for several reasons. Among these are:
Does Studycast negotiate contracts and budgets? Yes. Studycast negotiates contracts and budgets with Sponsors for all Studycast members. You will receive the proposed budgets and contracts after executing the Sponsor's Confidentiality Agreement. The budget and contract are submitted to you on an "As-is" basis as the budget and contract terms have already been negotiated by Studycast. Rest assured, that we have considered costs across all Studycast sites in negotiating our budgets. Because Studycast works with numerous geographically dispersed sites and numerous sponsors, we have experience upon which to draw. As a customer solutions group of ClinDev - a fast-growing niche CRO, we avail ourselves of ClinDev's proprietary training in negotiations to ensure that your study agreements are fair and profitable to your site. Does Studycast offer assistance with pre-initiation regulatory documents? Yes, as part of our service, Studycast offers assistance with regulatory document preparation and tracking. Does Studycast require any special computer hardware or software? Yes, Studycast is optimized to run on Microsoft Internet Explorer 4.0 or higher. This is typically the only technical requirement. You can download Microsoft Internet Explorer by clicking on the banner in the right border of this page. |
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