Project Management

Comprehensive Project Management Services

ffective project management is at the heart of successful clinical research. At Bioforum, we believe that strong project oversight drives efficiency, fosters collaboration, and ensures high-quality outcomes. Our dedicated Biometrics Project Management Office (PMO) supports every stage of the project lifecycle—bringing consistency, visibility, and strategic coordination across functions and trials.

Project Initiation

Establishing clear objectives, success criteria, and shared expectations.

Project Planning

Building detailed timelines, resource strategies, and action plans tailored  to each study.

Risk Management

Identifying potential issues early and implementing proactive mitigation strategies.

Monitoring & Control

Tracking progress, milestones, and deliverables to keep teams aligned and accountable.

Quality Assurance

Ensuring deliverables meet regulatory and industry standards—on time and on spec.

Stakeholder Engagement

Facilitating clear, consistent communication with sponsors and internal teams.

Project Team Composition

Our experienced Biometrics PMO team is dedicated to ensuring project success through strategic oversight and expert execution.

Biometrics Project Manager (Biometrics PM)

Leads the project, overseeing scope, resources, risks, and final delivery.

Biometrics Project Manager Associate (Biometrics PMA)

Supports the Biometrics PM in planning, execution, and stakeholder coordination.

Seamless Transition from SDTM to ADaM

Supporting consistency across datasets.

Regulatory Biostatistics Support

Strategic input for FDA/EMA meetings and submissions

Benefits of Our PMO

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Consistency & Standardization

Our PMO ensures consistency across all projects by providing unified processes, tools, templates, and best practices. This foundation supports high-quality, reliable, and efficient delivery—critical in the regulated world of clinical trials.

Governance & Oversight

We serve as the central hub for project visibility and control. With proactive monitoring of timelines, budgets, scope, and quality, we help identify risks early, support informed decision-making, and guide timely course correction  when needed.

Cross-functional Coordination & Knowledge Sharing

The PMO brings people and disciplines together. We promote collaboration across Data Management, Biostatistics, Medical Writing, and Project Management, ensuring smoother handoffs, fewer silos, and shared learning.

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Discover how our Project Management expertise can drive efficiency and success in your clinical research.

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Frequently Asked Questions

In what therapeutic areas does your medical writing team have experience?

Our medical writers have experience in a wide variety of therapeutic areas including Neurology, Oncology, Infectious Diseases, Immunology, Genetics, Computational Biology/Bioinformatics, Pharmacology, Hematology, Drug Development, (AI-based) Medical Devices and Molecular Diagnostics.

What is your typical turnover time for a clinical study report/clinical study protocol/journal article?

The amount of time to complete a writing project varies significantly between projects. The complexity of the studies and the development program are the primary factors in determining the time to completion of a writing project. A few additional factors are the amount of literature searching that is required (i.e., if the Sponsor can provide a literature collection, this would be a good way to accelerate the writing process), the clarity of messaging (i.e., the clearer we are on expectations at the outset, the faster we can write) and availability of reviewers to provide input on the delivered drafts. We discuss the timeline in the kickoff meeting and assign two writers per project, to increase writer availability and allow for concurrent work, where applicable.

What is the average price for writing a clinical study protocol/report/journal article?

We prepare a unique proposal for each project. Our unit of pricing is hour of work and our basic process comprises a shell document, three full drafts, quality checking and publishing. The effort estimation includes internal review and oversight by a team leader. We also offer a timed contract model, in which a writer is fully dedicated to a client and can work on multiple projects. This model is offered on a full- or half-time employee (FTE) basis, for 3-, 6- or 12-month contracts. This model also includes support from MW team leaders.