Pharmaceutical / Biotechnical: Development Phase


Learn How MasterControl Supports the Process of the Companies during Pharmaceutical / Biotechnical Development Phase

The development phase of drug discovery is the most important and arduous. Beginning with human trial protocol development and ending with the IND/ NDA submission to the FDA, the work to be completed and managed can become a company-wide effort. Small and mid-size companies are building out infrastructure, while ranking industry is adding significantly to its marketing and sales department, which can mean workflow changes while training new employees. The volume of documents to route and manage becomes monolithic in proportion, and waiting to organize it for the NDA submission can seriously jeopardize the quality of the submission and prolong the approval process. If companies have not organized and managed documents from scientific research through each phase, the workload can shut down company operations by inhibiting critical processes such as marketing, and keeping other pipeline products from moving forward. Out-of-the-box software solutions for collecting, organizing, and managing all the documents generated during the development phase can rapidly produce results, as can Change Control and Audit software.

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Biotechnical Development Phase Software Solutions

  • MasterControl Documents
  • MasterControl Collaboration
  • MasterControl Out-of-the-Box Solutions

Controlled Documents Managed in the pharmaceutical Development Phase

Collaboration Workflows in the Biotechnical Development Phase

  • Phase II protocols and investigator packets
  • Study reports and Phase II trial results
  • Adverse event and efficacy data
  • FDA Phase II submission and communication required to advance to a Phase III clinical trial
  • Phase III protocol design and templates used by investigators and CROs
  • Phase III clinical trial results
  • NDA submissions and FDA correspondence
  • Statistical data to include tables and listings
  • Documents related to product labeling and packaging
  • Medical communication programs such as publications, presentations, and speakers bureau information
  • Quality Assurance inspection methods and plans
  • Manufacturing plans and GMP record keeping
  • Quality plan
  • Quality SOPs
  • Clinical trial supply documents
  • Manufacturing build-out documents and assessments
  • Global marketing plan
  • Product lifecycle management evaluations
  • Site compliance reports
  • IRB reports
  • Phase II clinical trials:Collaboration between internal work groups such as discovery and development research, regulatory, manufacturing, marketing, and external CROs and vendors provides all of the information about the clinical trials and their results. Documents are circulated between internal teams and externals stakeholders such a principal investigators (PIs) prior to FDA submission.
  • Phase III clinical trials:Once the final human trial is completed, work commences on the NDA submission, which includes the trial results in addition to the IND, Phase I, Phase II and other potential studies and data on the product. Again, collaboration between internal work groups such as discovery and development research, regulatory, manufacturing, marketing, and external CROs and vendors provides the information needed about the studies and their results.
  • Product Labeling and Promotional Materials:Sales and marketing professionals collaborate with the regulatory team and legal on product labeling, packaging, and related items.

MasterControl Collaboration Pharmaceutical Development Phase Software Benefits

  • Provides a web-based, virtual workspace for collaboration.
  • Eliminates the need for face-to-face meetings between internal work groups such as discovery and development research, regulatory, manufacturing and others who review data from clinical trials and collaborate on regulatory submissions.
  • Facilitates the efforts of CROs and others external to the company to provide information and collaborate on documents in FDA submissions.
  • Creates "system transparency", so that authorized users can see where submissions and other documents are in the review process.

Biotechnical Development Phase Software Solutions for Managing Processes

The volume of documents to route and manage can become overwhelming during the development phase if companies wait to organize it for the NDA submission. MasterControl provides two out-of-the-box solutions for helping companies collect, organize, and manage all documents necessary to satisfy FDA submissions requirements.

  • MasterControl GCPDocs Spark
  • MasterControl GCPDocs

Contact Us for Biotechnical Development Phase

For more information about biotechnical development phase, feel free to contact MasterControl representative.