Pharmaceutical / Biotechnical: Definition Phase

How MasterControl Supports the Cross-Functional Team of Medical Device Companies in Pharmaceutical / Biotechnology Definition Phase

During the definition phase, the IND is developed and submitted to the FDA, and the Phase I dose- ranging study is designed, so that, once the IND is approved, the study can immediately begin. Collaborative teamwork and workflow processes dramatically increase to support the initial drug filing and prepare for subsequent studies. A number of teams within the company (such as discovery and development research, regulatory, manufacturing, business development, and quality) work together to align FDA approval strategies and support effective go / no go decisions for senior management. The legal department, which is responsible for patents, is also highly engaged and must be immediately informed of decisions and changes. A secure, web-based, document management system for providing data and customized reports in real time can have a huge impact on the success of the company during the product definition phase.

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Definition Phase Software Solutions

  • MasterControl Documents
  • MasterControl Collaboration
  • MasterControl Out-of-the-Box Solutions
Controlled Documents Managed in the Definition Phase Collaboration Workflows in the Definition Phase
  • Investigational New Drug (IND) application that includes all scientific study data
  • Phase I protocol design
  • Correspondence with the FDA
  • Initial CMC plans
  • Formulation descriptions
  • Design specifications
  • Intellectual property documents
  • Regulatory documents
  • Quality reports and documents
  • Product budgets and financial statements
  • Procurement and Contract Research Organization (CRO) plans
  • Presentations of business cases and go scenarios
  • Market and competitive analyses
  • Initial outline of Phase II and Phase III protocols
  • Drug substance studies
  • IND development and submission: As part of the IND, all pre-clinical work on the new chemical or biologic entity must be reviewed and properly organized according to FDA standards. Information regarding plans going forward such as CMC, Phase I, and expectations of future clinical trials must be communicated to the FDA.
    • Discovery research works with the development research and regulatory teams to assemble, review, and write reports on the new chemical or biologic entity that are organized according to FDA standards
    • Discovery research works with the development research and regulatory teams to develop the protocols and expected statistical outcomes for Phase I studies, as well as to outline initial subsequent clinical trials.
    • The manufacturing and development research teams collaborate on formulation development for Phase I studies; they also collaborate on the planning/coordinating efforts necessary to ensure clinical trial formulation supply.
    • In addition, the manufacturing, discovery research, and development research teams work together on advancing formulations that will be launched five years out.
  • Phase I dose-ranging study design and execution: Once the IND is approved, the company quickly moves into the initial safety testing required to study the product in human trials. Several departments are involved in the test design and subsequent report for FDA approval.

Pros of MasterControl Document Control and Management Software in Pharmaceutical Definition Phase

  • Secure, centralized virtual vaults provide effective organization and management of regulatory filing documents and support documentation.
    • This makes it easy to retrieve documents to share with external scientific and medical experts.
    • It also facilitates the retrieval of documents during inspections and audits.
    • Dual passwords, password expiration, and encryption secure data communication between the web browser and MasterControl applications.
  • Files and documents reside within a "draft" vault while being worked on, and, when approved, automatically move to the "approved/ released" vault.
    • This prevents sending incorrect or incomplete information to the FDA by enabling the regulatory team to lock down final versions.
    • It makes it easy to locate documents that will be part of the IND submission to determine their status.
    • And it avoids duplicated effort. A document under revision can be locked to prevent multiple users from simultaneously making the same changes to the document.
  • Automatic archiving and cataloguing of "outdated" documents provides a GxP-compliant audit trail.
  • Because the software is web-based, documents can be accessed by authorized users from any location.
    • This is helpful when working with contract manufacturing organizations (CROs), especially if they are outside of the country the product is being developed in.
    • A web-based document repository also enables off-site employees and experts to collaborate on documents. (Note: requires MasterControl Collaboration software.)
  • Software-generated reports provide information in real time to project managers, collaborators, and senior managers to help move processes and projects forward.
  • Document routing, delivery, escalation, and approval are automated, so that project management plans can synchronize teams and keep projects moving smoothly forward.
    • The system notifies team members in an approval workflow when a new document requires their attention, which improves the efficiency and effectiveness of project management.
    • When necessary documents can be escalated to the next level of responsibility to avoid bottlenecks.
  • Electronic approval capabilities and signature manifestation satisfy FDA requirements.
  • Analytics capabilities and online charting assist with presentations to senior management and other stakeholders and facilitate the decision-making process.
  • Auto load functionality enables users to drag-and-drop new documents into preconfigured network folders, making it easier and faster to load documents into the system.

Collaboration Software Benefits for Biotechnical Definition Phase

  • Provides a web-based, virtual workspace for collaboration.
  • Eliminates the need for time-consuming, face-to-face meetings and facilitates communications among cross-functional team members, the CRO, and other external resources, all of whom work together on the many details associated with developing and submitting the IND, as well as designing, executing, and reporting on the Phase I dose-ranging study.
  • Enables team members who may be offsite to collaborate.
  • Provides the ability "to chunk data" for particular audiences or purposes.
  • Creates system transparency, allowing authorized users to see where collaboration and FDA documents are in the workflow.

Pharmaceutical Definition Phase Solutions for Companies Who Lacks in Controlling Documents and Managing Processes

MasterControl provides two out-of-the-box, easy-to-implement solutions for helping companies collect and organize the documents necessary to satisfy all FDA submissions requirements.

  • MasterControl GCPDocs Spark
  • MasterControlGCPDocs

Learn More About Pharmaceutical and Biotechnical Definition Phase

To have more details about the pharmaceutical definition phase and biotechnical definition phase, feel free to contact MasterControl representative online.