Pre-Clinical

With mounting competition and patents expiring on older drugs, pharmaceutical companies are under greater pressure than ever before to bring new drugs into the pipeline and get them to market faster, more efficiently and at lower cost. Paragon provides preclinical pipeline acceleration solutions that deliver automated integration, statistical analysis capabilities and timely reporting. These solutions are built on a foundation of experience in data integration and solving the challenges that life sciences companies continue to face. Only Paragon provides a solution framework dedicated to preclinical reporting. And, while our framework accelerates implementation with predefined components and architectures - each client will have a seamlessly integrated, custom-tailored solution that meets individual needs.

Lab Operations
The rapid growth of candidates generated from discovery demands a more aware preclinical laboratory environment. Paragon's Laboratory Operations solution speeds information consolidation and improves awareness across lab operations with:

• Near real-time updates of project status with consistent notification of, and preparation by, contributors
• Resource allocation reporting to promote efficiencies of laboratory assets
• Comprehensive project rankings to resolve competing project bottlenecks
• Automated business status reporting to free-up technical staff

The efficiency gains from Paragon's Laboratory Operations solutions will create a competitive advantage with tangible increases in laboratory capacity.

Candidate Development
With more candidates to manage, organizations need a more sophisticated method of managing candidate development - both at the individual and portfolio levels. Paragon's Candidate Development solutions help you manage development projects so you know more and deliver more.

The project visibility capabilities of Paragon's Candidate Development solutions enable better control of project costs, more effective planning and portfolio rebalancing.

Analytic Genotype Tracking
With the need for creating a new process for conversion of genotype data for statistical analysis, Paragon has designed and developed Analytical Genotype Database solutions. Currently, many pharmaceutical companies are just beginning to develop processes for the collection and pharmacogenomics analysis of genotype data. Paragon has developed solutions that help automate the migration of data from the labs into a database for both statistical analysis and publication. Part of this automated process includes the integration of genotype and clinical phenotype data for true pharmacogenomics analysis. Paragon has also produced unique database designs to prepare for the explosion of data when genome scanning becomes practical.

Case Study: Analytic Genotype DataMart - Paragon created a standard procedural method for loading genotype data into statistical programs to enable easier access to data for both analysis and publishing.

Genetic Sample Tracking
Paragon’s Genetic Sample Tracking solutions help genomics and pharmacogenomics operations manage the flow of genetic samples from original sample collection through destruction. Besides supporting all tracking issues (such as informed consent, anonymization, status requests, sample requests, patient-request and time-triggered destruction requests), these Genetic Sample Tracking solutions also are 21 CFR Part 11 compliant, thus helping to ensure proper quality control.

Case Study: Genetic Sample Tracking – Paragon provided the pharmacogenomics operations group with an automated method for tracking genetic samples that streamlines the tracking process, significantly reduces the cost of sample management and supports compliance.

Alliance Management
In an effort to drive growth, many companies are seeking alliance opportunities with third parties. The rate of failure for such alliances, however, is estimated to be between 50-70%. In order for a collaborative effort to be successful, it is imperative that there be a dynamic flow of information between the alliance partners. For companies co-developing drugs, Paragon has implemented Co-development Collaborative Portals. Collaborative Portals will allow partnering companies to share relevant information more quickly and efficiently than the current method of secure email. Documents, notes, and diagrams can be shared. In addition, chats or threaded discussion groups around particular topics can be initiated, tracked, and posted to allow for more ad hoc sharing of information. The end result of this portal is a true knowledge management repository of all relevant development information for the relevant product(s). Role based security is available to limit access to information by company, group or compound.

Case Study: Alliance Management - Paragon created a portal solution that streamlined the communication and information sharing capabilities between the collaborating firms, accelerating the drug discovery and research process.