Frequently Asked Questions

What does it cost to join your network?

There is no cost to joining our site network study email list. Our process of submitting a site's study interest, feasibility, confidentiality agreement, scheduling qualification calls and visits, and following up for study updates and next steps for your site is all done free of charge to your site.

Do we need to sign an exclusive agreement with Elias Research as our SMO?

No, our sites are welcome to work to find studies independently or through other Site Management Organizations or Study Networks.

 

How often do you send out clinical trials and in what Indications?

We email clinical trial opportunities 3-5 times a week across all Indications for all specialties. 

 

How do submit for clinical trial opportunities with Elias Research?

Your Site and PIs must pass a general screening check and if approved, will be invited to register with Elias Research to receive a Site Pin for each of your Locations and a PI Pin for each of your Investigators so that you can apply for studies within seconds.   We ask sites to review our weekly study opportunity emails and if interested in a particular study, apply for that study by submitting the Site and PI Pins and answering a few questions about thee site's interest and/or history in that indication.

How often does it take from submission to selection?

The average timeline between study submission and site selection averages eight (8) months, but can be as quick as a few months or over a year. We welcome our sites to request an emailed  Study Tracker that will contain a list of all their studies and the latest updates for those studies.  We will also notify sites with general Study Updates when a study has moved to an important stage, such as scheduling PSVs or sending out selection notices to all sites who have applied so they can know how quickly or slowly a study is progressing.

 

How is Elias Research reimbursed for their Services?

Study Identification and Start-Up services are performed free of charge until your site is selected on a trial, at which point we receive a portion of the Start-Up for our services in finding the study and document submission and a portion of visit procedures for our services in Contract/Budget negotiation and payment processing. Our policy is that we should not receive any payment from our sites unless our site receives payment for a clinical trial first.

Elias Research acts as Payee on studies that our sites are selected for. We guarantee a five day payment turnaround to your site for any payments received for your site so that your site can be paid as quickly as possible.

 

If our site is selected, what will the Contract/Budget negotiation process look like?

Our policy is that sites can be involved in the negotiation process as little or as much as they wish. We send copies of all budget/contract documents to sites during each round of negotiations and ask for any specific feedback or requests from the site within a certain timeframe. If we receive this information within the request timeframe, we will ensure it is incorporated into our negotiations.

If we do not receive any response from our sites during that timeframe, we will proceed with negotiations as scheduled and notify your site upon receipt of a second draft budget and contract.

If your site is not satisfied with the final budget and contract, your site is under no legal obligation to accept or proceed with the clinical trial.

 

What can our site do to improve our chances of selection?

PI/Site Experience. We advise our sites to not apply for every trial we send out but focus on the trials that they have clinical trial experience in or a relevant patient population for to help their site stand out to the CRO and/or Sponsor.

Data Integrity. We ask our sites to be accurate and consistent in the information that they provide for the Sponsor in our online Representation Agreements and in the Feasibilities that we send to them. We want our sites to show strong attention to detail because skipping questions or errors, such as putting an email address or a phone number in for a question about previous trial experience, will disqualify your site from consideration with a CRO and/or Sponsor.

Responsiveness. We advise our sites to respond to all email requests or phone messages within 3 business days. Even if the requested information/action has not been obtained or completed yet, an update as to your progress on the request is a great reflection on your site’s ability to communicate well and successfully navigate a clinical trial. Sites that do not respond to emails or messages for 3+ weeks will be considered for removal from our network.

(Sample) Representation and Payment Policy

  1. Institution Authorizes Elias Research Associates, LLC a Study Management Organization (SMO), to submit their Site and Principal Investigator (PI) information to the pharmaceutical Sponsor (Sponsor) and/or Contract Research Organization (CRO) in response to the clinical research opportunity for this study as a potential participant in this study. Institution further authorizes SMO to create an Elias email account for their PI, so that SMO can receive study information on Institution’s behalf for the purposes of this study
     

  2. Institution Agrees that this study opportunity came from Elias Research, and consents to have Elias Research represent them as their SMO for this study. Institution does not have an exclusive Agreement with SMO and is only contracted to work with SMO on studies for which this Agreement has been signed, including all related protocols and potential extension studies. This Agreement can be voided if Institution can provide documentation verifying prior contact predating this Representation Agreement for this study upon receipt of unblinded Protocol and Sponsor information.
     

  3. Institution Agrees that if Institution is selected by the Sponsor or CRO for participation in this Study;

    • that SMO will negotiate the Contract and Budget on behalf of the Institution with the Sponsor or CRO. However, Institution will be encouraged to provide input throughout negotiations and provide final approval of the contract and budget. Institution is not obligated to sign the contract if the budget does not cover site costs.

    • that SMO will be Party to the Contract and the Institution will not conduct this Study directly with the Sponsor or CRO without written permission from SMO.

    • that SMO will be Payee on the Contract.

    • that SMO will make payment to Institution within five (5) business days of receipt of funds and corresponding payment details from CRO or Sponsor. SMO assumes no financial liability in the event funds are not made available by CRO or Sponsor. In the event of non-payment by CRO and Sponsor, Institution, and Principal Investigator’s exclusive cause of action for non-payment shall be against CRO and/or Sponsor

  4. Institution Agrees that neither the Institution, its employees, contracted personnel or PI, to the best of its knowledge after diligent inquiry, has been:

    • charged or convicted with a federal or state offense,

    • been debarred or disqualified from participating in clinical research by any regulatory authority, state or federal agency (21 U.S.C. §335a),

    • excluded by the Office of Inspector General or any state agency from participation in any federal or state health care program (42 U.S.C. §1320a-7 and 21 C.F.R. 312.70).

    • SMO reserves the right to remove any Institution and/or Investigator from the network at any time and for any reason deemed by SMO to be potentially detrimental to SMO's business.
       

  5. Institution Agrees that they will be subject to immediate removal from the Elias Research network of sites for any of the following occurrences:

    • Willful misrepresentation of Institution and PI information in terms of previous trial experience, potential patient population, PI experience, staff credentials, or other related information.

    • Institution’s failure to refund unearned study monies to SMO within 30 business days of notice pursuant to Section 11.

    • Institution’s failure to attend a Pre-Study Visit without prior notification.

    • Institution’s regular display of lack of timely response to email or phone communications.

    • Any proceedings related to Section 4 in terms of debarment or disqualification at the Institution.

  6. Institution Agrees that the Start-Up Fee will be subject to a flat rate fee proportionate to the Amount paid by the Sponsor or CRO as shown below. The SMO uses this fee to cover the time and expense associated with finding studies, submitting site information and documentation, and providing contract and budget negotiation expertise. (Ex: If Start-Up = $9,000, Site Receives $6,000)








     

  7. Institution Agrees that SMO will apply an 8% standard margin to the Budget that SMO negotiates with the Sponsor. SMO will apply this margin prior to payment to the Institution on the following items:

    • Per-Patient Visit Procedures and Payments (hereinafter referred to as “Visit Costs”)

    • Unscheduled Visits when costs are calculated from procedures that are itemized as Budget Line Items in the Visit Costs

    • Screen Failures when costs are calculated from procedures that are itemized as Budget Line Items in the Visit Costs

    • Invoiceable Expenses when costs are calculated from procedures that are itemized as Budget Line Items in the Visit Costs

    • Pass-through Fees with Overhead
       

  8. Institution Agrees that the below fees are exempt from the 8% margin and will be paid 100% to the Institution:

    •   Any Invoiceable Procedures that are not itemized as Budget line items in the Visit Costs and are not paid with overhead:

      •  Imaging procedures (MRI, XRay, CT Scan, etc.) that are not itemized as Budget line items in the Visit Costs and are not paid with overhead

      •  Significant medical procedures (colonoscopy, sigmoidoscopy. e TVU, etc.) that are not itemized as Budget line items in the Visit Costs and are not paid with overhead

      • All pass-through 3rd Party Vendor Costs (Advertising, Dry Ice, etc.)

      • All other pass-through expenses (Pharmacy, Close Out, Archiving Fees, etc.)

      • Subject Stipends, including travel and meal stipends

    •   Screen Failures that are paid at a flat rate less than the screening visit rates, and are not itemized as Budget line items in the Visit Costs and are not paid with overhead

    •   Unscheduled Visits that are paid at a flat rate and are not itemized as Budget line items in the Visit Costs and are not paid with overhead
       

  9. Institution Understands that SMO may choose to lower their standard margin at SMO’s sole discretion if the budget is deemed too low to cover fair market values and if multiple Sites on a study indicate special hardship.
     

  10. Institution Agrees that any taxes due and payable as a result of the payments by SMO to Institution shall be Institution’s sole responsibility. Institution further agrees to comply with all applicable state and federal tax reporting laws and regulations for any and all payments received from SMO.
     

  11. Institution Agrees that if any payments are made to the Institution in excess of work actually performed (i.e. refundable per patient advances, refundable start-up fees, etc.), Institution shall refund to SMO any and all excess funds within 30 days of receipt of notice from SMO.
     

  12. Institution Agrees to utilize a Central IRB for the purpose of this study.
     

  13. Institution Agrees to carry General Liability Insurance while working with Elias Research and will provide proof upon request if Institution is chosen to participate in a Clinical Research Study.

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