Study Start-up

LBR recognizes that project success rate is highly dependent upon well-executed startup planning.

Our dedicated Study Start-up group offers clients site feasibility, regulatory document collection and investigator site contract/budget negotiation.


Site Feasibility and Selection

The Site Feasibility process begins with a scientific review of the protocol and/or synopsis and development of a potential site list. This is followed by the development of a feasibility questionnaire by the LBR clinical team, in conjunction with Sponsor requirements. The questionnaire is used to screen investigator sites for interest, qualification, access to subject population and site capacity/resources.

Information on each site’s IRB requirements, timelines, additional review committee, and special requirements are included in the Site Feasibility process. LBR reviews the site’s responses and provides the Sponsor with a go/no-go recommendation for a Pre-Study Visit.

Site Feasibility Services Include:

  • Generation of Feasibility Questionnaires
  • Checking FDA Investigator Debarment Lists
  • Generating Potential Site Lists
  • Collation of a site’s IRB Requirements including timelines for submissions (if using a local IRB)
  • Recommendations for Pre-study Site Visit

Note: pre-study monitoring visits must be completed prior to formal approval of study participation.

Investigator Site Contracts and Regulatory Document Collection

Due to our extensive work with many institutions, LBR can leverage years of experience to anticipate the types of contractual language needed to facilitate the contract negotiation process.

Once a site is approved for study participation, regulatory documents and investigator site contracts/budgets are negotiated simultaneously, unless the site has different conventions. The site is also asked for any additional institutional sub-committees required prior to initiating the start-up process. During the pre-study visit, LBR can begin regulatory document collection to expedite site start-up.

Start-up Services Include:

  • Site Identification & Selection of Investigative Sites
  • Scheduling Pre-study Qualification Visits
  • Preparation and Collection of required Site Regulatory Documents
  • Investigator Contract & Budget Negotiation
  • Review of ICFs & Advertising
  • Central IRB Filings
  • Oversite of Translations (as dictated by study needs)
  • Ongoing Updates to Regulatory Documents
  • Investigator Site Payment