top of page
Image by Julien Maculan

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.

Image by Amy Hirschi

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,

​

  • 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

  • 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

  • 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.

  • 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:

  • the outsourcing of one or multiple functions, such as data management or monitoring,

  • a hybrid between FSP services and full-service outsourcing (FSO), and

  • 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

  • fixed price,

  • full-time equivalent (FTE),

  • unit-based,

  • output- or performance-based,

  • time and materials.

Image by Andreas Klassen

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:

  • shifts costs from direct to indirect to give more flexibility and allow right-sized workforces,

  • has expertise in Acquired Rights Directive (ARD) laws and regulations with an 87% average transfer success rate,

  • eliminates risks involved in hiring and layoff cycles, and condenses vendor contracts to reduce legal, financial, and ongoing oversight burden.

Image by Christina @ wocintechchat.com

Medical writing

  • Protocols for both interventional and non-interventional trials or investigations

  • Informed consent forms

  • Data management plans, statistical analysis plans, monitoring plans, site operational manuals, etc

  • Clinical study reports: interventional and non-interventional trials

  • Product or disease registries

  • Manuscripts, posters, and presentations for the trial result publication

Statistical design and analysis

  • Protocol document review for consistency, completeness and clarity

  • Creation of electronic Case Report Forms (eCRFs)

  • Deployment of electronic data capture system

  • Site support, data cleaning and quality control processes to ensure data integrity

Quality Assurance

  • 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.

  • NORTH AMERICA
    Headquarter 4130 Parklake Ave, # 202, Raleigh, NC 27612 Tell: 984-884-6888 Email: info@bioficher.com
  • LATIN AMERICA
    Buenos Aires, Argentina Avda. Del Libertador 7270, 19th Floor C1429, Buenos Aires C1429 BMS Mexico City, Mexico Gustavo Baz #315 Edificio A-1 Piso 1 Fraccionamiento Industrial La Loma Tlalnepantla, EMEX México City, México C.P. 54060
  • EUROPE
    Amsterdam, The Netherlands Oval Tower De Entrée 99 197, 14th floor 1101 HE Amsterdam, The Netherlands+31 (0)20 3018 500 Barcelona, Spain L’Illa Diagonal Avenida Diagonal 571-M3-3rd Floor 08029 Barcelona, Spain+34 93 255 5600 Belgrade, Serbia Starine Novaka 23 11000 Belgrade, Serbia +381 11 715 8044 Bucharest, Romania Str. Tudor Arghezi No 8 UNIMED Center Building 6th floor, Room A2
  • ASIA PACIFIC
    Adelaide, Australia Level 24, 91 Westpac House King William St. Adelaide, 5000, Australia Bangkok, Thailand 23/F M Tower, All Seasons Pl 87 Wireless Road Lumpini, Phatumwan Bangkok 10330 Thailand Beijing, China Block C 5th Floor, Yintai Centre No. 2 Jiang Guo Men Wai Street Chaoyang District Beijing, China 100022 Hong Kong Level 23, One Island East 18 Westlands Road Hong Kong Tokyo, Japan Urbannet Nihonbashi 2-Chome Building 5F, 2-1-3 Nihonbashi, Chuo-ku Tokyo 103-0027 Seoul, South Korea 4F, Gangnam N Tower 129 Teheran-ro, Gangnam-gu Seoul, South Korea 06133 Singapore 21 Biopolis Road, #03-03 Nucleos Singapore 138567 Mandaluyong, Philippines BioFicher Sciences Philippines, Inc. 9th Floor, The Podium West Tower 12 ADB Avenue, Ortigas Center Mandaluyong 1555 Philippines
  • MIDDLE EAST
    Mar Roukoz, Lebanon Berytech Technological Pole 1107 2240 Mkalles, Lebanon
  • AFRICA
    Lagos State, Nigeria 183 Primerose Tower, Adeola Odeku Street 3rd Ground Floor Lagos State, Nigeria 23401 Bloemfontein, South Africa 183 Nelson Mandela Drive, Ground Floor College Court Bloemfontein, South Africa 9301 Cairo, Egypt Florida Tower El Sheikh Aly Gad El Haq St. 1229 Square, Sheraton Buildings, 8th Floor Heliopolis Cairo, Egypt
  • CARDIOVASCULAR & NEUROVASCULAR
    We work to deliver innovations that extend and improve the lives of people with cancer.
  • OPHTHAMOLOGY
    We work to deliver innovations that extend and improve the lives of people with cancer.
  • INFECTIOUS DISEASES AND VACCINES
    Infectious Disease research is a dynamic space requiring nimble and innovative solutions. Our team of infectious diseases and vaccines experts respond to the need for speed and flexibility through novel trial design and technology solutions that allow for real-time data delivery.
  • ONCOLOGY & HEMATOLOGY
    We work to deliver innovations that extend and improve the lives of people with cancer. Our work in oncology
  • PEDIATRICS
    We work to deliver innovations that extend and improve the lives of people with cancer.
  • CELL & GENE THERAPY
    Cell and gene therapies offer tremendous promise where traditional treatments fall short. These innovative therapies require charting new, riskier territory. Our multi-disciplinary cell and gene therapy teams are poised to help you bring life changing treatments to patients earlier.
  • CENTRAL NERVOUS SYSTEM
    Delivering novel CNS therapies is scientifically, medically and operationally complex. At BioFicher, we have more data and insights than ever before to drive innovation forward. With over three decades of experience across neurology, neurodegenerative diseases, psychiatry, sleep, CNS rare diseases and pain, our CNS team can help you design and deliver complex clinical trials.
  • ALLERGY & RESPIRATORY
    Your goal is to differentiate and deliver the best respiratory treatment in a competitive arena. Rely on BioFicher’s insightful and actionable analytics and technology platforms to successfully help you meet those challenges.
  • MEDTECH/MEDICAL DEVICE
    Encompasses our capabilities in digital therapeutics, medical device, and diagnostics — supporting your needs in every therapeutic indication. SCHEDULE A CONSULTATION WITH OUR MEDTECH EXPERT
  • WOMEN HEALTH
    Disease and treatment impact women differently than men. That’s why women’s health research deserves a specialized approach.
bottom of page