With the sweeping changes of mega mergers and rapid technology change in the biotech and pharmaceutical industry, the revolution in genomics and high throughput discovery is unprecedented.  To create more effective drugs, companies are transforming one-size-fits-all therapies into treatments with products that are tailored for an individual's makeup by now focusing on the disease’s root causes.  This transformation in the industry has also created an unprecedented opportunity for laboratory software solutions that can provide the necessary tools for companies to compete effectively and efficiently in this new high-volume discovery landscape.  By employing high throughput informatics tools and expertise, Companies can accelerate the discovery process and bring their drugs to market faster.

It is no surprise that research and drug discovery environments face unique challenges and therefore require purpose-built data management tools that are very different from traditional laboratories that employ traditional LIMS as their data management solution. Customers who are "discovery oriented" versus "data collection oriented" must look to intelligent LIMS that contain built-in knowledge about business processes and study management tools to help them:

• Screen drug candidate smarter and fail poor candidates faster
• Manage standard and complex study protocols
• Enable collaborative research and sharing
• Acquire, analyze and run complex calculations and statistics on huge volumes of data, in multiple formats
• Review, summarize, document and present data in effective reports for rapid review and approval
• Automate, integrate and manage equipment and data
• Accelerate decision making - Create an information rich environment (knowledge) in order to make better decisions and sooner…not just the data anymore
• All while complying with fierce regulatory requirements!

Typical generic LIMS do not offer off-the-shelf functionality that address the unique needs of plate handling for early stage research, DMPK calculations for mid discovery research and study/trial management for late stage development.  Thermo Scientific addresses these needs with its rich functionality and flexible framework of Nautilus, Galileo and Watson LIMS.

For early stage research, Nautilus LIMS™ LIMS is extremely flexible and offers significant advantages for high throughput screening laboratories that require plate handling by providing:

• A turnkey solution
  • Purpose-built for discovery labs
  • Easily configurable – requires no programming
  • Easily connects to most major test and measurement devices
  • Simple and automated dissemination of information
• Complete audit trails and traceability functions that comply with FDA regulations (21 CFR Part 11) i.e. record functions, users, time stamps, electronic signatures, etc.
• Daughter plate production
• Reformatting, re-racking and cherry picking for 96/384/1536 plate types
• Extensive automated workflow engine capability to address procedures, instrument sequences, business rules, etc.
• Easy integration of barcodes
• Real time and historical trending of data

Galileo LIMS™ for mid discovery research, offers specific advantages over manual data processing using spreadsheets where many or all in vitro processes are performed manually and data is transcribed by copy-&-pasting, where files can be misplaced or lost or stored on local PC not server.  Galileo incorporates and automates these processes allowing for standardized methods and procedures, integrated instrument interfaces and a centralized data storage area.   Galileo’s fully integrated system for In Vitro ADME includes:

• Scheduling assays and planning tasks using workflows
• Creation of unique experimental assay designs
• Extensive Instrument Interfacing
  • Instrument sequence file creation
  • Instrument data file import
• Calculation of industry standard in vitro parameters
  • Automatic recalculation after outlier removal
• Full graphing of analytical results
  • Presented in interactive gallery or detailed view for faster decision making
• Automated Data Status flagging
  • Save, Accept, Reject, Unaccept
  • Ability to add comments to analyzed result data
• Industry Standard Descriptive Statistics
  • Mean, SD, %CV, N, minimum, maximum
• Integrated audit trail, e-Signatures and granular security

Watson LIMS™ for late stage development, is in 19 of the top 20 pharmaceutical companies around the world providing them the functionality, flexibility and scalability that meet their needs both today and in the future.

• Full security and complete compliance confidence
  • Provides a system with all the  21 CFR Part 11 components you need to achieve compliance, including integrated audit trail, e-Signatures and granular security
• Automation improves study data workflow
  • Allows a full bi-directional interface capability to analytical instruments, tracks shipments and samples through user-designed barcode labels, supports a wide range of analyses, and organizes study results in a unique document management system
  • Includes automated assay acceptance and rejection tool
• Enterprise-wide knowledge and collaboration
  • Permits improved collaboration and data transmission between sites, systems and customers currently using Watson LIMS™
• Robust, dynamic reporting
  • Supports built in reporting and document management system, with full chain of custody reports for sample tracking
  • Includes a comprehensive regression calculation tool, complete with linear and non-linear algorithms and many weighting factors

In Good Company
Here’s a sampling of drug discovery and research companies who count on Nautilus, Galileo and Watson LIMS: Abbott Labs, Allergan, Amgen, Apotex, AstraZeneca, BiogenIdec, BristolMyersSquibb, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche, SanofiAventis, Vertex and Wyeth. 

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Pharmaceutical Manufacturing
The pharmaceutical industry is unique in many ways.  The challenges facing pharmaceutical companies, including large pharma, biotech and generic manufacturers are sometimes overwhelming.  Diverse laboratories, regulatory constraints, complex batch management and testing needs all demand sophisticated, enterprise-level informatics solutions.  In this regard, data collection can be both a burden and the solution, for validation comes through information, but the systems that provide the information must themselves comply with the regulatory requirements they work to satisfy.

Some of the key challenges that Pharma laboratories face when selecting a LIMS include:

• Supporting the diversity of laboratories and users (from combinatorial screen, preclinical, clinical bioanalysis, manufacturing R&D and production quality control) with their unique needs and workflows
• Intense regulatory scrutiny means a solution must satisfy both internal and external auditors, including the flexibility to support widely varying review and approval workflows for static data (product specs, study protocols) and dynamic data (test results, batch disposition)
• Pressure to streamline and become more efficient across businesses with clearly demonstrated cost justifications

For pharmaceutical companies choosing a Laboratory Information Systems (LIMS), there are three primary alternatives: a custom-built system, a customized generic system, or a purpose-built solution.  Purpose-built solutions have been developed with pharmaceutical needs in mind, reducing risk and costs due to the constant need for re-validation which is inherent in software customization when any component is modified. 

Thermo Scientific’s Darwin LIMS™, was developed specifically to meet the needs of pharma development and QA/QC by delivering a high percentage of required functionality out of the box.  You can count on Darwin to deliver:

• Many features aimed at ensuring compliance with FDA and international regulatory requirements, including those of the ICH guidelines and regulations across the world
  • ICH-compliant templates are included to let users build stability protocols and studies as quickly as possible
• A unique batch and product oriented design that aligns directly with pharmaceutical manufacturing processes, allowing R&D and production data to be logically organized, summarized and reported
• More flexibility for R&D.  By flagging the R&D data the user knows it does not necessarily meet the requirements that clinical or production data would. If other departments want to use the data, it would then be subject to all of the regulatory requirements (e.g., changes would be documented and audit trails would be generated when the data was accessed).
• Environmental monitoring to the list of out-of-the-box functionality. Standard requirements of pharmaceutical companies, previously added via customization or implemented as an additional module in a generic LIMS, are now included in Darwin as standard functionality requiring minimum configuration.
• Reduced customization means reduced validation, shortened deployment and easier ongoing support
• Customer-defined compliance configurations, auditing, electronic signatures and justifications can be tailored to meet every department needs
• Data can be assigned to the appropriate compliance level to allow researchers greater flexibility during exploratory work, while still enforcing adherence to company SOPs and regulatory guidelines for cGMP quality control data
• Comprehensive test library including test methods for dissolution, drug release, dosage unit uniformity, product assays, and a stability module that simplifies the process for designing, implementing and managing stability studies
• Interfaces with enterprise systems (Document Management, MES, ERP, etc.) and allows for interactions with other data treatment applications.  Integration tools provide a graphical environment to build bi-directional instrument interfaces and application level interfaces
• Easy user acceptance and simple GUI build on Microsoft .NET technology for flexibility and ease of use.  User-based profiles preserve individual user preferences, and administrators can easily modify screens, create new functionality and develop version and privilege controlled reports using standard tools such as Microsoft Visual Studio.
• Reduce risk of protocol deviations by tracking inventory and providing notifications
• Report and filter data easy and rapidly without IT intervention
• Standardization for global and multi-site harmonization

By delivering extensive pharmaceutical functionality in the base system, Darwin LIMS™ can help companies lower their total cost of ownership (TCO) of their LIMS by reducing the time it takes to implement, validate, achieve user acceptance and maintain system upgrades, all while improving productivity and end-user experience.

In Good Company
Here’s what people are saying about Darwin: “On looks alone, Darwin wins the coolest GUI award.  Sleek interface, simple commands, placing power at the fingertips, it seems that Darwin is a complete re-think of the LIMS interface.” Jeff Vannest, J&R Consulting Inc., LIMS Consultant

In addition, Darwin is built incorporating technology and intellectual property developed through our extensive experience in the pharmaceutical development and QA/QC marketplace. The following are examples of companies running Thermo Scientific's previous generation LIMS for this market: Abbott Labs, Amgen, AstraZeneca, BMS, GSK, Pfizer, Sanofi Aventis, Servier, J&J, Elan, Noven, and AMO to name a few.

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Contract Research Organizations (CROs)
To stay competitive and agile in an ever increasing and complex environment, pharmaceutical and biotech companies are outsourcing more and more research spending.  The result of this is that Contract Research Organizations (CROs) have seen exponential growth by offering a more focused and expertise-rich approach to their services. The major success factor of CRO providers is based on being able to deliver market-specific, high-performance technology with expandable capacity and quicker delivery speed.  CROs must employ tools to help them integrate their data to speed their processes and to connect with their customers outside of the laboratory.

CROs Have Special Requirements for their LIMS
CROs, because their activities serve the needs of many different clients, have special considerations when it comes to LIMS implementations. They generate large volumes of data for complex studies, and transmitting that information to the customer in a secure and meaningful way is paramount.  When it comes to data security, online access includes both traditional IT security and security designed to keep one customer's data private from other customers. 

In addition, CRO’s must differentiate themselves by providing superior customer service and techniques that allow them to rapidly reconfigure solutions to meet the needs of a variety of customers.

It is no surprise that CRO environments face unique challenges and therefore require purpose-built LIMS tools that are very different from conventional laboratories that employ traditional LIMS as their data management solution. Customers who are "study oriented" versus "data collection oriented" must look to purpose-built LIMS to help them:

• Screen smarter and faster while reducing operating costs
• Acquire, analyze and run complex studies (including calculations and statistics) on huge volumes of data, in multiple formats
• Review, summarize, document and present data in effective reports
• Provide their customers with secure and easy access to their data
• Automate, integrate and manage equipment and data
• Increase productivity, lower operating costs, and improve quality and customer service
• Accelerate decision making i.e. create an information rich environment (knowledge) in order to make better decisions and sooner…not just the data anymore!
• All while complying with fierce regulatory requirements

Typical generic LIMS do not offer off-the-shelf functionality that meets the unique needs of CROs.  Thermo Fisher Scientific addresses these requirements head on with its rich functionality and flexible framework of Watson™ LIMS by delivering:

• Full security and complete compliance confidence
  • Provides a complete 21 CFR Part 11 compliance system and full study audit trail
• Automation to improve study data workflow
  • Allows a full bi-directional interface capability to analytical instruments, tracks shipments and samples through user-designed barcode labels, supports a wide range of analyses, and organizes study results in a unique document management system
• Enterprise-wide knowledge and collaboration
  • Permits improved collaboration and data transmission between sites, systems and customers currently using Watson LIMS™
• Robust, dynamic reporting
  • Supports built in reporting and document management system, with full chain of custody reports for sample tracking
  • Includes a comprehensive regression calculation tool, complete with linear and non-linear algorithms and many weighting factors

Thermo Scientific enables the CRO market to meet its aggressive business and technology requirements by equipping laboratories with a scalable, easy-to-configure automation solution, providing CRO laboratories a competitive advantage and superior customer service.

Watson is in the Bioanalytical labs of 19 of the top 20 pharmaceutical companies around the world providing them the functionality, flexibility and scalability that will meet customers' needs both today and in the future.  CROs who follow their lead will be well positioned to provide services to the giants of the industry.

In Good Company
Here’s a sampling of Contract Research Organizations who count on Watson in their laboratories: Advinus, Bioassay Laboratories, Bioclin, Charles River Laboratories, Glenmark, HFL, Inveresk, MDS Pharma Services, Parexel International, Quest Pharmaceutical Services, Quintiles, SFBC International, Tandem Labs and Veeda Clinical Research.

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