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CROMOS TM PHARMA FINANCIAL ASPECTS OF PROJECT COORDINATION ( interaction with Finance in the process of project coordination ) Alexey Melkov, Associate Director , Business Development. PROJECT COORDINATION. Project 1 Project Manager: (local) project management Monitor: monitoring
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CROMOSTM PHARMA FINANCIAL ASPECTS OF PROJECT COORDINATION (interaction with Finance in the process of project coordination) Alexey Melkov,Associate Director, Business Development
PROJECT COORDINATION Project 1 Project Manager: (local) project management Monitor: monitoring Monitor: monitoring Project 2 (Lead) Monitor: project coordination + monitoring Monitor: monitoring Project 3 (Lead) Monitor: project coordination + monitoring
FINANCIAL INFORMATION Service Work performed (service units done / milestones achieved) to date (required for invoicing) Work (service units / milestones) planned till the end of the project (required for planning future cash flow) Pass-through expenses Actually incurred expenses (required for invoicing) Planned / anticipated expenses (required for planning expenses)
PROJECT STATUS REPORT (PSR) Project ID Service (obligatory) Scope of work (service units to be performed) Work (service units) performed to date Work (service units) planned till the end of the project Project Metrics (optional) Timelines Enrollment
WORK WITH PSR For now Complete monthly / in real time Send monthly to finance@cromospharma.com Save previous copies for future reference In the near future (via Office 365) Complete monthly / in real time No need to send No need to save copies manually (automatic versions created)
WORK WITH PSR (stages) BD / Finance creates PSR – when? Call to discuss Project coordinator completes the report Finance reviews / corrects the PSR asks the project coordinator for clarifications discusses with Business Development / Director Finance issues invoices / plans future cash flow Finance provides an updated version to the project coordinator BD provides a new version to the project coordinator
SERVICE UNITS Other contracts: MRT, X-ray, lab Subsequent submissions to RA / LECs: end of study, annual study status, protocol amendments, SUSARs CTS = study drug, lab kits, CRFs, comparator Site management: from first site initiation to last site close-out Local project management: from start of Cromos involvement to the very end of the project Telecons with the sponsor: formalisedcalls Internal telecons / short reg. meetings: minutes!
NOTA BENE Do not forget about DM, BS & Medical writing Do not change past units Do not drag & drop cells Unit is considered to be done when it is obvious for the client (maybe later than actually performed) Project transfer = PSR transfer Project Metrics (optional) Timelines Enrollment (names of sites, please)
SCOPE OF WORK (SOW) Operational SOW ≥ Financial SOW For project coordinator (operational SOW) Work (service units) that can be performed Any evidence of client’s obligation to pay OR approval / political decision by Cromos management available Big question: can we do it? Ideally: no out of scope work should be done For Finance (financial SOW) Work (service units) that can be invoiced (are invoicable) Covered by contract / amendment Big question: can we invoice it? Theoretically: no out-of-scope units can be invoiced
SCOPE OF WORK (SOW) Operational SOW ≥ Financial SOW Not all the units that can be performed (= are within the operational scope) can also be invoiced (=are within the financial scope).
PASS-THROUGH COSTS Info about budgeted PTs to be provided to the project coordinator together with PSR Actual pass-through costs Confirmed by payment docs As soon as possible Planned / anticipated pass-through costs Get OOSPTs pre-approved by the sponsor Should be advanced by the sponsor Can be anticipated by Finance based on PSR (service units) Project coordinator’s support appreciated
PASS-THROUGH COSTS vs OUR SERVICE Service units not associated with specific PTs (e.g. project-specific contract template) Services units accompanied by PTs (e.g. visits) Pass-through costs not associated with specific service units (e.g. translations) CTS ≠ курьерка Outsourced services presented to the client as service (not pass-through), e.g. DM, BS
ПРИВЕТ ОТ КАТИ Sitemanagement выставляется с визита инициации, а не с начала проекта; СTSshipmentsfrom/tosites - какие виды отправок имеются в виду; Submissions, contractswithsitesetc.- выставляются, когда документы получены спонсором, а не тогда когда работа проводилась; Translations - дать разъяснения по различию переводов в РТ и Сервис (перевод в офисе или в агентствах). Многие не знают разницы; Делать примечания к ячейкам: если визит, то имя монитора, дата визита и номер центра, если подписание контракта, тономер центра; если последующие подачи, то каких док-тов
PROJECT STATUS REPORT (PSR) Needed for Finance Useful for Management Useful for project coordinator