FSP 360
Providing an array of FSP 360 services anytime during the clinical development lifecycle
BIOFICHER FSP SOLUTIONS DELIVER THE TOP-TIER EXPERTISE YOU WANT AND THE ON-TIME DELIVERY YOU NEED
The pharmaceutical industry is constantly in motion — drug patents expire, new therapies emerge, portfolios expand, and life-changing compounds make their way to market. As a result, it’s critical for drug developers to engage a partner that can navigate these changes and predict and manage the resources needed for projects to be successful.
EXCEEDING TIMELINES IS A HUGE MOTIVADELIVERING THE RIGHT EXPERTISE FOR EVERY FSP ENGAGEMENTTOR FOR US.
Because you can’t always predict — or find and retain — the staff and services you need, our experts deliver more experience, knowledge and a wider breadth of expertise than other functional service providers, uniquely positioning us to provide the right experience and knowledge to fill immediate gaps,
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BioFicher FSP solutions provide access to a wide range of reliable and customizable resources to support key functional areas, fill gaps in internal capabilities or enhance functional expertise. We act as a true partner to help solve your resource challenges and provide support for clinical and marketed products across every aspect of a drug development program — from site startup and monitoring to clinical data management to post-approval strategy. We position biotech and pharmaceutical companies for success.
FLEXIBLE, PERSONALIZED SOLUTIONS
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It’s important to find the right solutions to your resourcing challenges. BioFicher FSP solutions offer customized engagements tailored to your exact needs and requirements. Our FSP services are available across all functions, from clinical services to marketed products, and are available worldwide, for one-off and large-scale projects — and everything in between.
INDUSTRY-LEADING SCALE
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Site identification, recruiting, selection, activation, and monitoringWhen you need to scale a project, our FSP services have the scope to make it happen. Rely on our more than 30,000 research professionals across the globe who can provide you with the support you need, when you need it.
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The extensive breadth and depth of our services for clinical trials and marketed products spans all phases, therapeutic areas, and levels (including senior roles) in 160 countries. This allows BioFicher FSP solutions to function as a single partner for your projects.
DELIVERY MODELS TAILORED TO YOUR NEEDS
Strategically selecting the right outsourcing models can bend the cost and time curve of drug development by maximizing quality, operational success and financial efficiencies. Pharmaceutical companies employ a variety of models to meet that need, including FSP services. When using FSP services, models include:
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the outsourcing of one or multiple functions, such as data management or monitoring,
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a hybrid between FSP services and full-service outsourcing (FSO), and
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customized FSP models.
FLEXIBLE ENGAGEMENTS TO ACHIEVE PROJECT GOALS
The flexibility of using different engagement models — or a blend of those services — means you can always choose what is right for you. An engagement with BioFicher FSP solutions is always customized to your requirements.
We partner with you to offer the best FSP model for your project needs, including a flexible mix of systems, processes, oversight and facilities — yours or ours. Our customers benefit from innovative pricing models that accommodate various contract structures from
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fixed price,
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full-time equivalent (FTE),
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unit-based,
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output- or performance-based,
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time and materials.
REBADGING EXPERTISE
In today’s drug development climate, organizations must ensure proper utilization across programs. BioFicher FSP solutions help you navigate staffing challenges by offering a dedicated staff transfer team focused on change management and business continuity. The staff transfer team:
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shifts costs from direct to indirect to give more flexibility and allow right-sized workforces,
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has expertise in Acquired Rights Directive (ARD) laws and regulations with an 87% average transfer success rate,
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eliminates risks involved in hiring and layoff cycles, and condenses vendor contracts to reduce legal, financial, and ongoing oversight burden.
Medical writing
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Protocols for both interventional and non-interventional trials or investigations
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Informed consent forms
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Data management plans, statistical analysis plans, monitoring plans, site operational manuals, etc
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Clinical study reports: interventional and non-interventional trials
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Product or disease registries
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Manuscripts, posters, and presentations for the trial result publication
Statistical design and analysis
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Protocol document review for consistency, completeness and clarity
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Creation of electronic Case Report Forms (eCRFs)
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Deployment of electronic data capture system
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Site support, data cleaning and quality control processes to ensure data integrity
Quality Assurance
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Auditing of study data, sites, laboratories, 3rd party vendors, and Contract Research Organizations (CROs) to ensure operations follow established procedures
FSP SOLUTIONS
By choosing an experienced, industry-leading functional service provider for one or multiple services to deliver the right experience and knowledge to fill immediate clinical development resource gaps, you gain flexibility and financial efficiencies, allowing you to focus on your areas of expertise.