Pharmaceutical / Biotechnical: Concept Phase

How MasterControl Supports the Cross-Functional Team of a Pharmaceutical / Biotechnology Concept Phase of the Companies during Process

The concept phase in the pharmaceutical industry involves the development of new lead compounds that potentially afford a wide range of discoveries that shape the companies pipeline and market opportunities. Important information is gathered and must be prioritized and documented, not only for the sake of current research, but for determining strategic fits for future discoveries in potentially like platforms. The ability to transfer scientific notes and information from any source (including lab notebooks) into a centralized, web-based document repository provides scientists with valuable collaborative information. Often this information leads to exciting, new ideas that motivate market analyses and patent research, which, in turn, generate a great deal of investment interest within the company.

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Biotechnical Concept Phase Software Solutions
  • MasterControl Documents ™
  • MasterControl Collaboration ™
  • MasterControl Out-of-the-Box Solutions ™
How Controlled Documents Managed in the Biotechnical Concept Phase Collaboration Workflows in the Pharmaceutical Concept Phase

  • Lab notebook entries
  • Chemistry and pharmacology study data
  • In vivo study data
  • Biomarkers
  • Formulation studies
  • Statistical analyses
  • Market analyses
  • Potential revenue forecasts
  • Preliminary patent analyses
  • Corporate communications and investment presentations
  • GLP compliance documents
  • Chemistry and pharmacology research: Internal scientists share scientific information with one another and with external experts. New therapeutic targets are also shared with business development analysts, who determine potential revenues and differentiate potential drug candidates from other scientific platforms and emerging or current products.
  • Potential patent feasibility:; Because the value of life science products relies on the intellectual property assigned to them via patents, early stage products are initially reviewed in a broad category of areas by the cross-functional development team, senior management, and experts outside the company to ensure that the additional resources expended on product development will be justified.
  • Market and fiscal analysis:Senior managers, business development executives, and manufacturing must stay current on scientific platforms and the capabilities of scientific discovery. The focus is generally on specific targets and therapeutic areas, which determine the strategic direction of the company as a whole. Managers ultimately responsible for supporting products with specialized services are required to report on feasibility, while business development analyzes the market relevance of specific therapeutic targets.

Benefits of Document Control and Management Software for Pharmaceutical Concept Phase

  • Secure, centralized repository for storing scientific notes (including lab notebook entries, which can be scanned into the system)
    • Centralized document repository makes it easy to find the latest version of all documents.
    • All lab notebook entries and other documents are catalogued by subject matter and dated to make them even easier to find.
    • Security features include dual passwords for document approval, password expiration, encryption, and certification, as well as account lockout to prevent unauthorized users from gaining system access...
  • A time-stamped audit trail, reporting, and electronic signature capabilities fully satisfy FDA 21 CFR Part 11 requirements.
    • Time-stamped audit trail capability makes it easy to reconstruct scientific research during investigations.
    • Lead generation and other reports can be scheduled to print automatically on a regular basis, or they can be requested on the fly to access data in real time.
    • Electronic signature capability authenticates document approvals.
  • MasterControl automates routing, delivery, escalation, and approval of documents to facilitate organization and ensure access to the most current version of all scientific and research documents.
    • This prevents collaboration documents that have not been approved from being accidentally released.
    • It also avoids duplicated effort. (A document under revision can be locked to prevent multiple users from simultaneously making the same changes to the document.)
    • And it makes it easy to locate a particular study document to determine its status.
    • The ability to track scientific and research documents by status (in process, complete, or history) enables users to review the revision and approval history.
  • Automatic archiving and cataloguing provides a GxP-compliant audit trail.
  • Reporting and analytics capabilities, including customizable reports and online charting, facilitate the efforts of research scientists, market analysts, and senior management.
  • Auto load feature enables scientists and market analysts to drag-and-drop new documents into preconfigured network folders, making it easy to load documents.
  • MasterControl Documents connects with all quality sub-systems such CAPA, Nonconformance, Deviations, Change Management, Audit, and Training.

Benefits of MasterControl Pharamaceutical Concept phase Collaboration Softwares

  • Web-based structure enables individuals, both inside and outside the company, to collaborate on the development of new lead compounds.
  • The ability to collaborate provides critical early-stage feedback from manufacturing and business development on issues such as feasibility and therapeutic target market rationale.
  • The ability "to chunk data" for a particular audience or purpose can facilitate the collaborative effort with outside resources and provide more effective company presentations.
  • Creates system transparency for authorized users, allowing senior management and members of the cross-functional development team to monitor scientific discovery progress.

Solutions for Companies Who Don't Have Software for Controlling Biotechnical Concept Phase Processes

MasterControl offers two out-of-the-box solutions to help small to mid-sized pharmaceutical and biotechnical companies collect, organize, and manage all the documents necessary to meet FDA submissions requirements and standards.

  • MasterControl GCPDocs Spark
  • MasterControl GCPDocs

Contact Master Control for Pharamaceutical Concept phase

For more information about biotechnical concept phase, please feel free to contact MasterControl representative today.