• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Biotechnology’s Role in Improving Stroke Outcomes

    CEO Spotlight: Marc Kikuchi

    Newsmakers: Darren Shirley

    Are You Prepared for the 2023 DSCSA Deadline?

    Rethinking the Changing Role of the CRO
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    BioIVT Acquires Scottish Drug-metabolizing Enzyme Manufacturer Cypex

    Schott Creates Stand-Alone Company for its Pharma Business

    Marken to Acquire Medical Courier Business of Cedra Express

    Porton’s New Crystallization and Drug Product Facility

    Thermo Fisher Expands NY Cell Culture Media Manufacturing Site
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Marken to Acquire Medical Courier Business of Cedra Express

    Porton’s New Crystallization and Drug Product Facility

    Thermo Fisher Expands NY Cell Culture Media Manufacturing Site

    Woodstock Sterile Solutions Fills Two Leadership Roles

    SmartLabs To Open New Facility in Philadelphia
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Marken to Acquire Medical Courier Business of Cedra Express

    5 Key Features of Agile Pharmaceutical Packaging Supply Chains That Drive Results

    Novavax Expands Manufacturing Agreement with SK bioscience

    Lonza Continues to Lead the Market with Innovative Hard Empty Capsules

    Sharp Expands Reach to China Through Partnership with ClinsChain
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Thermo Fisher Expands NY Cell Culture Media Manufacturing Site

    Thorne HealthTech, AstraZeneca Entend AI Discovery Alliance

    Gilead Sciences to Acquire MiroBio for $405M

    Amgen to Acquire ChemoCentryx for $3.7B

    BioNTech, Genmab Expand Global Strategic Oncology Collaboration
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Chime Biologics Receives Commercial Manufacturing License

    Automation Is Key to Meeting Demands in Pharmacovigilance

    UBC Acquires Examoto

    Responding to Consumer Complaints While Working with CMOs

    WuXi Vaccines Receives GMP Certificate from HPRA
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Qosina

    Biosynth Carbosynth

    CMC Pharmaceuticals

    Kyongbo Pharmaceutical
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Qosina

    Biosynth Carbosynth

    CMC Pharmaceuticals

    Kyongbo Pharmaceutical
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Expert's Opinion

    Pharma’s Imperative: Rethinking the FSP Outsourcing Paradigm

    Evaluating outsourcing strategies amid a complex trial landscape to further enhance clinical operations.

    Pharma’s Imperative: Rethinking the FSP Outsourcing Paradigm
    Related CONTENT
    • CPhI North America Event Info
    • Legacy Pharma Solutions
    • PCI Pharma Services
    • Lonza Further Invests in Drug Product Manufacturing Capabilities
    • Recro Pharma Signs Renewable Energy Agreement with Georgia Power
    Michael D. Jones , Vice President of Clinical FSP Client Engagement, IQVIA08.17.20

    2020 is proving to be a year to remember, with the healthcare industry navigating through difficult circumstances and the unknown around COVID-19 to continue drug development for patients in need. But, in many ways, we could just add these challenges to the ongoing list of trial complexities that have helped fuel the continued increase in cost for clinical development. The pressure is on for the pharmaceutical industry to reduce cost and improve speed of treatment development while keeping up with ever-changing regulatory updates and increasing competition. And, as trends show the cost of drug development outstripping revenue growth, this is more critical than ever.

     

    Amid a complex trial landscape, heavy focus on specialized treatments in developed markets, patient-centric digital health integration, and more, change is coming to a head for the industry. Whether already contracting for functional service partnerships or considering them, an increasing number of companies are evaluating their outsourcing strategies to further enhance clinical operations, data sciences, and safety or regulatory components of drug development.

     

    The need for enterprise-wide transformation

     

    Over the years, the use of Functional Service Provider (FSP) outsourcing solutions has increased among large, multi-national pharmaceutical firms to mitigate growth in fixed cost and derive flexibility in resource management.  Use of traditional approaches to FSP outsourcing can lead to as much as 15 percent in savings compared to hiring full-time employees. Traditional models for FSP outsourcing typically rely on multi-vendor approaches to resource provision, siloed by functional capability (e.g., data management, clinical monitoring, and statistical programming) and geography. And, often, these models use the company’s internal processes and systems to support completion of the work performed by the third party resources.

     

    Though intended to support and enhance efficiencies within the functionally-aligned components of a company, FSPs may also need to evolve and go well beyond siloed flexible staffing solutions to deliver additional efficiency, speed, and precision to cope with the challenges facing the industry.

     

    Considering focused shifts

     

    Currently, FSP models can help decrease the cost of labor, but recent innovations in automation to leverage artificial intelligence, machine learning, and advanced analytics can actually help reduce the effort required to perform certain tasks.

     

    Removing effort while simultaneously focusing on enhanced quality and predictability through data-driven insights is contributing to significant efficiencies in some labor-intensive segments of the clinical development enterprise. For example, it is well-known that clinical monitoring can make up as much as 35 to 45 percent of total costs for a clinical trial. Powerful centralized monitoring solutions can be a cornerstone of an up-to-date FSP approach and can help cut these costs and improve overall effectiveness. A clinical research organization partner capable of providing a centralized solution with real-time data analytics and AI/ML-enabled workflows can help study teams more efficiently improve data quality, ensure site compliance, and stay on top of patient and site risk management. At IQVIA, this advanced approach to clinical monitoring is fueling a transformation of clinical operations, removing up to 40% of effort required historically as on-site monitoring visits.

     

    When evaluating how new FSPs can create efficiencies, it is worth considering a larger discussion with FSP partners that asks what core components of clinical development the company needs to own, and what can be taken on better by valued third-parties. In flushing out collaborative efforts to meet the demands of future drug development, it is proper to not only look to FSPs for staffing solutions but also to leverage and integrate their resources and technologies, including comprehensive SaaS-based platforms, which can further streamline processes toward efficiency and precision — not work in parallel to them.

     

    The earlier in the strategy and design process that sponsors can involve and engage FSP partners, the better. Co-designing solutions for individual customers based on their specific business objectives from the start can help identify all of the potential capabilities and tech-enabled solutions that may bring benefit: opportunities to increase efficiencies in a specific function, geography, and other functional components that integrate to most effectively execute clinical trials.

     

    Reducing inefficiencies that cost time and money and keep patients waiting for therapies they need has always been a challenge for clinical development. Now, the industry is better equipped with innovative solutions and capabilities to overcome this challenge. And, as we live through the effects of a global pandemic, it may be the ideal time to push ourselves harder for renewed thinking about how to collaboratively improve the design of FSPs to more efficiently meet business objectives and patient needs for innovative medicines.
     


    Since joining the pharmaceutical industry in 1982, Michael has garnered experience in a variety of leadership roles spanning a multitude of clinical development disciplines including Product Development, Clinical Operations, Regulatory Affairs, Information Systems, Quality, and Compliance.

     
     
    Related Searches
    • Clinical Trials
    • Drug Development
    Suggested For You
    CPhI North America Event Info CPhI North America Event Info
    Legacy Pharma Solutions Legacy Pharma Solutions
    PCI Pharma Services PCI Pharma Services
    Lonza Further Invests in Drug Product Manufacturing Capabilities Lonza Further Invests in Drug Product Manufacturing Capabilities
    Recro Pharma Signs Renewable Energy Agreement with Georgia Power Recro Pharma Signs Renewable Energy Agreement with Georgia Power
    November 2021: Auction of Pharmaceutical Equipment from Intec Pharma Ltd. November 2021: Auction of Pharmaceutical Equipment from Intec Pharma Ltd.
    Symbiosis Completes Successful MHRA Audit Symbiosis Completes Successful MHRA Audit
    Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals
    Hookipa Enters Clinical Collaboration & Supply Agreement with Merck & Co. Hookipa Enters Clinical Collaboration & Supply Agreement with Merck & Co.
    Interpreting Pharma Regulations & Staying Compliant Interpreting Pharma Regulations & Staying Compliant
    Aurion Biotech Makes Strategic Investments in Manufacturing Aurion Biotech Makes Strategic Investments in Manufacturing
    COVID Booster Vaccines: What’s Next for FDA COVID Booster Vaccines: What’s Next for FDA
    The Future of Clinical Trials The Future of Clinical Trials
    Trust, but Verify Trust, but Verify
    Let’s Get Genuine Let’s Get Genuine

    Related Live From Shows

    • CPhI North America Event Info

      CPhI North America Event Info

      ...
      04.21.22

    • Legacy Pharma Solutions

      Legacy Pharma Solutions

      ...
      Nathan Bender, Director, Sales & Marketing 12.07.21

    • Drug Development
      PCI Pharma Services

      PCI Pharma Services

      ...
      Jessica Kloster, Marketing Manager 10.20.21


    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
      Lonza Further Invests in Drug Product Manufacturing Capabilities

      Lonza Further Invests in Drug Product Manufacturing Capabilities

      New filling line to process various modalities, including monoclonal antibodies, bioconjugates, viral vectors, and other gene therapy products.
      09.22.21

    • Breaking News | Formulation Development
      Recro Pharma Signs Renewable Energy Agreement with Georgia Power

      Recro Pharma Signs Renewable Energy Agreement with Georgia Power

      Will purchase 1.2 million renewable energy credits through Georgia Power’s Simple Solar Program.
      09.21.21

    Loading, Please Wait..
    Trending
    • Gilead Sciences To Acquire MiroBio For $405M
    • Amgen To Acquire ChemoCentryx For $3.7B
    • BioNTech, Genmab Expand Global Strategic Oncology Collaboration
    • Bayer Opens New Research And Innovation Center At Kendall Square
    • Datwyler To Double Capacity At Production Ops In Pune
    Breaking News
    • BioIVT Acquires Scottish Drug-metabolizing Enzyme Manufacturer Cypex
    • Schott Creates Stand-Alone Company for its Pharma Business
    • Marken to Acquire Medical Courier Business of Cedra Express
    • Porton’s New Crystallization and Drug Product Facility
    • Thermo Fisher Expands NY Cell Culture Media Manufacturing Site
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Biotechnology’s Role in Improving Stroke Outcomes
    • CEO Spotlight: Marc Kikuchi
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    3i Solutions Announces New Leadership Positions
    INS Nutra Opens Gummy Manufacturing Facility
    Vital Nutrients Launches First Vegan Omega Supplement with SPMs
    Coatings World

    Latest Breaking News From Coatings World

    Custom Cars Featuring PPG DELTRON Refinish System Take Awards at Goodguys 24th Summit
    HGTV Home by Sherwin-Williams Announces 2023 Color Collection of the Year
    BASF to Produce More Specialty Pyrrolidones in North America
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Elizabeth Coleon Joins Withings as Chief Marketing Officer
    U.K. Strengthens Medical Device Regulations
    Fujirebio Acquires ADx NeuroSciences
    Contract Pharma

    Latest Breaking News From Contract Pharma

    BioIVT Acquires Scottish Drug-metabolizing Enzyme Manufacturer Cypex
    Schott Creates Stand-Alone Company for its Pharma Business
    Marken to Acquire Medical Courier Business of Cedra Express
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Body Shop Expands Partnership with Uber
    COSRX Launches Vitamin E Vitalizing Sunscreen
    Weekly Recap: Kylie Makeup Lab Controversy, Glossier Pivots to Retail and Wholesale & More
    Happi

    Latest Breaking News From Happi

    Dry Shampoo Brand Batiste Teams Up with Barry's Boot Camp to Give Consumers Post-Workout Refresh
    Watsons China Launches Health Care Zone Prompted by the Covid-19 Pandemic
    Earth Therapeutics Celebrates National CBD Day with Foot Balm-Enriched CBD
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Zeller+Gmelin, Epple Druckfarben Lead This Week’s News Stories
    A-Flex Label Adds Epson SurePress UV Digital Label Press
    Ball Announces 2Q 2022 Results
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eukalin acquires Adhesives Specialists
    EyeC unveils new inspection products
    Errol Moebius named VP of IST America
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: A New Day for Hygiene, Glatfelter Reports Q2 Results & More
    Dyper Achieves B Corp Certification
    Edgewell’s Sales Grow
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    NuVasive Inc. Reports Q2 2022 Financial Results
    Solid Growth Ahead for Carpal Tunnel Release Systems Sector
    ODT's Most-Read Stories This Week—Aug. 6
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: STMicroelectronics, NextFlex and onsemi Top This Week’s Stories
    Zebra Technologies Reports 2Q 2022 Results
    InnovationLab Demonstrates New PCB Production Method Based on Additive Manufacturing

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login