Project management

Real-world evidence and health economics studies present a project management challenge that is structurally different from interventional clinical trials. There is no single protocol start date that synchronises all activities. Data sourcing negotiations run on their own timeline, independent of study design. External data owners – national statistics agencies, hospital networks, claims administrators – operate under procurement and governance procedures that are not within the sponsor's control.

Ethics committee and information governance approvals proceed in parallel with data access negotiations. Analysis cannot begin until the data is ready, which depends on access that depends on governance that depends on approvals that all have their own lead times.

APICES provides project management for RWE and HEOR studies through an operational lead who understands the full dependency chain – from study design through data sourcing, governance, analytics, and reporting – and who builds a realistic plan against it from day one.

What RWE and HEOR Project Management Covers

• Study initiation: kick-off planning, stakeholder coordination, data source identification timeline
• Data sourcing management: vendor identification, governance document preparation, data access negotiation tracking
• Ethics and information governance: coordinating parallel submission processes across data holders
• Data delivery tracking: managing milestones from data request to data ready, with contingency planning for delays
• Analytics project management: sequencing analysis activities against data availability, managing interim review cycles
• Reporting and publication: managing CSR or study report delivery against analytical timelines
• Sponsor communication: structured status reporting adapted to the study's dependency structure

Accountability Across the APICES Delivery Model

Project management for RWE and HEOR at APICES benefits from the same integrated delivery model as the clinical trials side of the business. The project manager has direct access to the data management, analytics, medical writing, and regulatory alignment teams – all in-house. When a data access delay is going to push the analysis timeline, the medical writing team knows immediately and the reporting schedule can be adjusted before the sponsor's internal planning assumptions are compromised.

Multi-Country and Multi-Source RWE Coordination

Many RWE programmes require data from multiple European countries simultaneously – for example, a comparative effectiveness study that requires data from France (SNDS), Germany (GKV networks), and Spain (BIG-PAC). Each data source has its own access procedure, governance requirement, and data format.

APICES has managed multi-country, multi-source RWE programmes where data access negotiations run in parallel across three or more jurisdictions. The project management infrastructure for this – milestone tracking, governance document management, communication structures with multiple data owners – is built into the standard APICES delivery model for RWE studies.

What You Can Expect

• An operational lead who understands the RWE dependency structure – not an interventional trial PM applied to a real-world study
• Realistic study timelines built around actual data sourcing and governance lead times
• Parallel management of data access, ethics, and information governance processes
• Integrated coordination with data management, analytics, and medical writing in-house
• Structured sponsor reporting adapted to the study's dependency structure
• Multi-country, multi-source coordination experience across European claims and EHR data networks

Frequently Asked Questions

How does APICES project management handle data access delays?

Data access timelines are built into the study plan with explicit contingency buffers, and progress is tracked weekly against milestones. When delays emerge, the downstream impact on analytics and reporting is immediately assessed and communicated to the sponsor with options.

Can APICES manage studies with multiple data sources in different countries?

Yes. Multi-source, multi-country coordination is a standard capability. We have managed parallel data access negotiations across France, Germany, Spain, Italy, and the Netherlands within single study programmes.

How does RWE project management differ from interventional trial PM?

The dependency structure is fundamentally different. In RWE studies, the PM manages data sourcing negotiations, ethics and information governance approvals, and data delivery timelines that are outside the study team's direct control.

What does a typical RWE study governance meeting look like?

A weekly operational status call covering data access progress, analytics milestones, open risks, and sponsor decisions required – plus a monthly governance review with the full sponsor and APICES senior team.

Do you provide a single point of contact for multi-vendor RWE programmes?

Yes. APICES coordinates all data sourcing, governance, analytics, and reporting within a single delivery model. Sponsors have one PM and one operational structure – not a matrix of separate vendors with separate contact points.