Service Provider Qualification and Monitoring Processes at Science Exchange

October 9, 2017 | Posted by Team in Company, Outsourcing Best Practices |

R&D organizations are rightfully cautious when selecting service providers. So much is at stake — reputation, intellectual property, pipeline decisions, regulatory approval, financial investments, and time. ISO 9001 Certified QMS Science Exchange

By partnering with Science Exchange, R&D organizations can finally rest assured that they are accessing a network of service providers that meets their most stringent criteria for quality and integrity.

Put your reputation into the best hands.

Every service provider on the Science Exchange platform is rigorously qualified and operates under pre-established legal agreements that protect intellectual property (IP), define confidentiality obligations, and ensure quality and compliance.

We stand by the unmatched quality of our ISO 9001-certified service provider qualification and monitoring processes. Our process verifies details of service provider compliance, reputation, financial standing, and staff expertise:

Provider Qualification & Monitoring Criteria  

Compliance Reputation Financials Expertise & Resources
  • Basic info (contact, billing, shipping)
  • Proof of certifications
  • FDA warning letters
  • USDA violations
  • Anti-bribery/Anti-corruption*
  • Social media
  • Client referrals
  • BBB complaints
  • Website verification
  • Facility/operations photos
  • Tax documents
  • Financial standing
  • Risk assessment
  • Employee headcount
  • Staff bios
  • Instrumentation
  • Detailed service descriptions
  • Validation data
  • Publications/patents

We require submission of compliance and capabilities information to help our clients determine whether the provider is the best fit for a proposed study. Information is either incorporated into the Science Exchange storefront for each facility or is stored within Science Exchange’s database. *Science Exchange checks against FPAC enforcement actions for anti-bribery/anti-corruption compliance.

Request a demo to see how our service provider quality management system protects our partner R&D organizations.

Science Exchange Survey Reveals Pain Points of Outsourcing R&D

September 18, 2017 | Posted by Team in Company, Outsourcing Best Practices, Press Release |

Contract review, service provider qualification, and security of intellectual property among major concerns for biotech and pharma leaders surveyed at 2017 industry conferences

PALO ALTO, Calif.– More than 100 biotechnology and drug development leaders who responded to surveys conducted during industry conferences earlier this year reported a wide range of barriers to the outsourcing of research and development (R&D) services, including the contracts review process, intellectual property (IP) security concerns, and service provider qualification. The surveys were conducted by Science Exchange, the world’s leading and most secure platform for outsourced research and development (R&D), during the 2017 Biotechnology Innovation Organization (BIO) International Convention and 2017 Drug Industry Association (DIA) Global Annual Meeting.

More than 75 percent of Science Exchange survey respondents ranked the following concerns as barriers (a significant barrier or somewhat of a barrier) to the outsourcing of R&D services:

  • Having contracts reviewed and signed
  • Security of IP;
  • Identifying service providers with required expertise;
  • Qualifying service providers; and
  • Negotiating pricing.

Time management related to R&D outsourcing was also reported as having a significant impact on these R&D leaders, with over 40 percent of those responding to the survey indicating they spent more than 20 hours to onboard each new outsourcing partner, from the request for proposal process, through contracting and start of the project. Finally, further demonstrating the impact of the time spent on administrative tasks related to outsourcing, more than 75 percent of survey respondents reported that the “hassle” of bringing on a new partner has previously led them to choose an existing vendor rather than seek out a more qualified option.

“The results of this survey echo the same concerns we heard from the leading biotech and pharma companies who now rely on Science Exchange to help them efficiently manage their outsourced R&D services,” said Elizabeth Iorns, Ph.D., co-founder and CEO of Science Exchange. “In review of enterprise clients’ experiences, we find that our Science Exchange clients save thousands of work hours each year on procurement, business operations, contracting and legal resources, and administrative tasks related to outsourcing — time that can instead be spent in discovery. It’s gratifying to see that we’re able to fulfill our goal to support the scientific discovery process by removing barriers to innovation for our clients.”

See how your organization could streamline outsourced R&D through Science Exchange — request a demo of our platforms for enterprise clients.

Science Exchange Releases Latest Version of its Enterprise Dynamic Report Tool

September 11, 2017 | Posted by Team in Company, New Feature, Outsourcing Best Practices, Press Release, Science Exchange News |

Latest release gives enterprise clients access to real-time data to improve reporting and decision-making for outsourced R&D investments

Dynamic Report Tool

PALO ALTO CA, Sept. 11, 2017 – Demonstrating the company’s commitment to support its clients’ growth plans by optimizing data aggregation and business intelligence, Science Exchange, the world’s leading and most secure platform for outsourced research and development (R&D), recently released the latest version of its enterprise dynamic report tool. The tool enables Science Exchange’s enterprise clients, including some of the world’s top pharma and biotech companies, to perform real-time tracking of key performance indicators (KPIs) related to their outsourced R&D investments.

“The Science Exchange enterprise dynamic report gives me the ability to tease out diverse suppliers and export spend data. Our procurement management team has been thrilled with the report,” said Gregory Smith, Associate Director, Indirect R&D Procurement, Teva Pharmaceuticals Industries, Ltd.

This latest enterprise dynamic report update allows enterprise clients like Teva Pharmaceuticals Industries, Ltd., to:

  • Track spend, budget performance, and outsourcing efficiency in real time;
  • Gain visibility into service provider performance metrics; and
  • Better assess efficiency of outsourced R&D programs.

“With this dynamic reporting tool, our enterprise clients are able to gain a whole new understanding of category-specific purchasing behaviors within their organizations. R&D and procurement leaders can receive and proactively analyze – in real time – data and business intelligence that can help them quickly assess the performance and impact of their outsourced R&D programs, ” said Elizabeth Iorns, Ph.D., co-founder and CEO of Science Exchange. “Science Exchange helps our clients make data-driven business decisions, while at the same time giving researchers quick and secure access to more than 2,500 scientific service providers – allowing researchers to focus on innovation and discovery.”

Learn more about enterprise partnerships with Science Exchange, and request a demo of our private marketplaces for outsourced R&D:
www.scienceexchange.com/enterprise

 

Privacy Shield Certification Shows Our Commitment to Protecting Customer Data

July 20, 2017 | Posted by Team in Company, Outsourcing Best Practices, Press Release, Research, Science Exchange News |

Science Exchange First & Only R&D Outsourcing Platform to Receive EU-U.S. Privacy Shield Framework Certification

PALO ALTO CA, July 20, 2017 – Science Exchange today announced that it is the first and only R&D outsourcing platform to receive EU-U.S. Privacy Shield Framework certification from the U.S. Department of Commerce. This certification demonstrates the company’s commitment to the protection and privacy of sensitive data shared by its customers and scientific service providers on the Science Exchange platform.

Designed by the U.S. Department of Commerce, the European Commission and Swiss Administration, the EU-US Privacy Shield Framework provides companies with a method to conform to data protection requirements when transferring personal data from the European Union and Switzerland to the United States in support of transatlantic business. This new framework replaces the EU-U.S. Safe Harbor program.

“The privacy and security of data for scientific research is a top priority for our customers and service providers, and we saw this certification as an important step for Science Exchange, especially in light of recent cyberattacks that affected companies across the healthcare and biopharma industries,” said Elizabeth Iorns, Ph.D., co-founder and CEO of Science Exchange. “The thousands of companies that use the Science Exchange platform can be assured that we are committed to the protection of the personal and scientific data entrusted to us.”

To receive EU-U.S. Privacy Shield Framework certification, companies must commit to a range of data management requirements, including that they will:

  • Inform individuals about how their data is processed
  • Maintain data integrity and purpose limitation
  • Ensure accountability for data transferred to third parties
  • Review and certify that all requirements are met on an annual basis

In addition to being the only R&D outsourcing platform with EU-U.S. Privacy Shield Framework certification, Science Exchange is also SOC 2 compliant, which validates that the company meets standardized criteria for managing data privacy and security – a certification that is increasingly required by regulators and auditors. Science Exchange is also ISO 9001 certified, which recognizes that the company adheres to strict quality management principles and maintains a consistent quality assurance program.

For more details about the EU-U.S. Privacy Shield Framework, the certification process, or to view a list of participating companies, visit www.privacyshield.gov.

Read more about our certifications ensuring data security, quality management and privacy at www.scienceexchange.com/compliance.

 

Media contact:

Kerry Metzdorf
Big Swing Communications
978-463-2575
kerry@big-swing.com

Navigating the Fragmented Outsourced Manufacturing Sector

May 30, 2017 | Posted by Team in New Innovations, Outsourcing Best Practices, Research, Uncategorized |

Contract manufacturing of pharmaceuticals is growing rapidly and has recently seen an uptick in merger and acquisition activity, such as Thermo Fisher’s bid to acquire Patheon.  Despite the consolidation, outsourced pharmaceutical manufacturing remains a fragmented market, as outlined in a recent report and summary. Discovering and qualifying outsourced service providers is already challenging, and the persistent fragmentation compounds the challenges.

Science Exchange has a unique vantage point for evaluating contract manufacturing services based on our diverse client base and the associated customer experience scorecard data we gather. In this post, we share our insights around navigating the complex contract manufacturing sector.

Demand for contract manufacturing services

The high demand for external manufacturing capacity and expertise is one driving force behind the proliferation of CMOs and CDMOs. According to a 2016 survey, biopharma organizations cite the need to improve quality as the primary reason for using contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). Additional goals for outsourcing include reducing time to market, controlling costs, achieving supply chain diversity, leveraging regulatory expertise, and accessing specialized technologies, including those required for complex biologics manufacturing processes.

Competition between CMOs: Innovative manufacturing services

Competition in the marketplace is driving CMOs to develop innovative manufacturing technologies to capture new service categories — choosing a cutting-edge CMO partner can give a biopharma company advantages over its competitors.

Many CMOs and CDMOs have adopted process improvements to provide their clients with faster cycle times and more informed decision-making. These improvements include cloud-based computing, real-time risk-monitoring tools, and integrated quality-by-design during process development. Such process improvements are especially important given the ability of multiple CMOs to manufacture the same API. Nearly 90% of the volume of drugs sold are generic small molecule therapeutics, requiring high production capacity that may be provided by any number of CMOs.

Other CMOs differentiate themselves through specialized expertise – for example, they may be leaders in developing novel formulations, such as nanoparticles or lipid-based delivery systems. Some CMOs offer specialized regulatory certifications, such as CLIA/CAP, GLP, and GCP. Although cGMP compliance is not absolutely required for all CMOs, most reputable CMOs are cGMP certified.

Contract manufacturing of biologics and complex therapeutics: a growth opportunity

It has been challenging to outsource the manufacture of biologics, such as vaccines, therapeutic monoclonal antibodies, and cell therapies, and non-biological complex drugs. These fast-growing segments are faced with regulatory hurdles, a need for specialized drug delivery devices, and inherent risks involved in method transfer and ensuring consistent supply.

Despite the challenges of method transfer, technological improvements are facilitating partnerships between biopharma companies and CMOs in biologics pipelines. Emerging categories of therapeutics, such as cell therapies and antibody-drug conjugates, as well as novel formulations, such as nanoparticles, have benefited from specialized manufacturers. Even though some of these specialty drug products may require bespoke manufacturing processes, CMOs stay agile through integrated quality-by-design during process development and take advantage of connected single-use technologies for streamlined yet flexible bioprocessing.

Barriers facing discovery and qualification of manufacturing service providers

The demand for contract manufacturing, combined with the growth opportunities around innovation and biologics, have resulted in a marketplace with thousands of active CMOs and CDMOs. It can be time-consuming and difficult to identify qualified service providers with the right certifications to meet regulatory compliance requirements. Though many service providers are staffed by innovative, highly qualified scientists with experience in the biopharma industry, many service providers lack such expertise.

Because there are no clear third-party qualification processes or objective benchmarks for quality, and because biopharma companies lack the time to perform regulatory compliance audits of all the service providers in this fragmented sector, over 68% of biopharma companies use a preferred provider strategy for outsourced manufacturing. Relying on preferred providers may decrease the agility of companies to take advantage of emerging technologies.

For contract manufacturing to add maximum value to an organization, responsible teams should consider adhering to a defined sourcing strategy.

Checklist for a successful contract manufacturing partnership

To maximize the advantages offered by a successful CMO partnership, the procurement and external resource management teams of a biopharma company must ensure that their sourcing strategy includes:

  • Keeping abreast of emerging technologies and service providers;
  • Stringently qualifying service providers based on turnaround time, product quality, cost, and regulatory compliance;
  • Identifying service gaps and assessing value of existing preferred providers;
  • Streamlining the contracting process to enable rapid onboarding of innovative service providers;
  • Establishing contracts that protect intellectual property and confidentiality, to maintain competitive advantage and minimize risk;
  • Managing project milestones to ensure that projects are completed on time and as planned;
  • Keeping meticulous records so that methods can be transferred in house or to other service providers as needed.

Science Exchange  streamlines management of strategic manufacturing partnerships

Science Exchange, the largest marketplace for outsourced scientific services, enables biopharma companies to rapidly find and order cutting-edge technologies and services from a proprietary network of 2500+ qualified service providers, including many providers of contract manufacturing services.

Science Exchange’s Provider Management Team continually seeks to build its network by adding high-quality, innovative service providers with cutting-edge expertise in emerging manufacturing technologies.

Science Exchange’s dedicated staff scientists on our Sourcing Team help biopharma manufacturing teams find the best service provider for each scope of work, obtain multiple competitive quotes, and provide end-to-end project management. By using Science Exchange, manufacturing teams save hours or days per project that they would otherwise spend identifying providers, obtaining quotes, and managing projects.

Science Exchange mitigates inherent risks of outsourced manufacturing; all service providers on the platform are pre-qualified through a stringent vetting process and provides information on past performance, using an ISO 9001 Quality Systems-certified process.

Manufacturing scientists at top biopharma companies are already using Science Exchange to access hundreds of qualified specialty providers. The platform is enabling these scientists to order services from known and new manufacturing service providers, such as ImQuest, Almac Sciences, Recipharm, ChemPartner, Synovel Laboratory, Bioneer A/S, Solvias AG, WuXi AppTec, Lonza, and Piramal.

Contact Science Exchange today to discuss your manufacturing needs.

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