Clinical Late Phase and Post Approval Services

Delivering on Late Phase Studies Combining FSP and FTE Model along with Technology

Management of late phase studies pose various challenges to sponsors due to operational complexities, involvement of higher patient population, spread of the studies in different regions/countries and country specific various operational challenges. Though sponsors want to outsource these late phase studies to one or more vendors, they would like to have proper control at right places and time to ensure quality and efficiencies of the deliverables. Considering evolving needs of the industry at present, MakroCare offers mixed outsourcing approach with FSP, FTE model and technology to support sponsors as a single, full scope service provider for managing late phase studies.

Evolving Needs of Industry

Need of a flexible outsourced model to adapt to changing requirements of managing complexities and aggressive timelines of late phase studies
Better control of quality and time sensitive tasks, deliverables and thereby improving KPIs
Better control on the tasks such start-up activities, patient recruitment, monitoring, data quality, patient safety monitoring and data base lock activities
Efficient use of sponsors’ internal resources for critical tasks and outsource of routine, administrative activities to vendors

MakroCare for Late Phase Studies- Differentiators and Benefits

Our Capabilities / Differentiators	Benefits to Sponsors
Capability and capacity to support current industry trend to offer different combination of outsourcing models such as FSP, FTE or full scope service as per sponsors’ need	Sponsors have more flexibility to select outsource model to fit to their requirements
Offers backend services (CDM, Biostats and Medical writing) from a single cost-effective location as a part of FSP	Serves as one “Center of Excellence’ for all late phase studies from different regions where sponsors have better control over data
Offers FTE resources such local CRAs which would be working with sponsor POC and at the same time MakroCare would be responsible and accountable for the performances of the resources	Sponsor will have better control over key study deliverables related to start-up activities, patient recruitment, data quality, patient safety and database lock
MakroCare offers integrated approach by combing its services with its technology (mEDC, mIRT, TULA)	Cost effective and efficient approach from a single vendor to avoid delays & issues happening in coordination of two different vendors for service and technology
In house expertise and technology to adapt to new monitoring approaches such as risk based centralized monitoring	Sponsors will get consulting and hand-holding to adapt to these new monitoring approaches