Central Laboratory. As discussed with Sponsor, **** has been identified as suitable lab for the present Project. Estimated total pass-through costs have been added within the budget for PEP005-009.
Central Laboratory. SPONSOR will select and contract with a central laboratory for all clinical safety labs required by the protocol and TKL will manage all aspects from the site and laboratory perspective.
Central Laboratory. 8. Central Maintenance (Divisional Shops, Maintenance Training, Power, Reconditioning Shop, Maintenance Services) One (1) Representative 1. Central Maintenance (Divisional Shops, Reconditioning Shop, Maintenance Training, Maintenance Services) 2. Power
Central Laboratory. XXXXXXXXXX shall be responsible for making all necessary ------------------- arrangement for services from the central clinical laboratory ("CCL") selected by XXXXXXXXXX for tests specified by the Protocol. PPD shall review for completeness and accuracy all billing from the CCL and signify its approval for payment thereon. PPD shall on a monthly basis deliver to XXXXXXXXXX such xxxxxxxx for direct payment by XXXXXXXXXX to the CCL. EXHIBIT C PROPOSAL -------- EXHIBIT D TIMELINES --------- ESTIMATED DURATION OF PPD ACTIVITIES Letter of Intent (LOI) signed, begin identifying investigative sites .....................Completed Final Protocol received at PPD .............................................................Month 0 Investigative sites identified ...........................................................Month 0.5 Begin obtaining IRB approvals ............................................................Month 1.0 Study Drug available .....................................................................Month 1.5 Patient enrollment ......................................................................Months 2-7 Active patient participation ..........................................................Months 2-8.5 Last CRF to PPD data management ...........................................................Month 10 Last data query to PPD data management ....................................................Month 11 Transfer of original investigative files to XXXXXXXXXX ....................................Month 12 Total PPD Commitment: 12 Months EXHIBIT E
Central Laboratory. 15.1 Identification of Central Laboratories X 15.2 Pre-Qualification Audit of Central Laboratories X 15.3 Selection of Central Laboratories X 15.4 Payment of Central Laboratories X 15.5 Management of Central Laboratories X 15.6 Organise Project Teleconferences X 15.7 Provide status reports X 15.8 Review of clinical laboratory data X 15.9 Lab Data transfer to study database X
