Pharmaceutical / Biotechnical: Feasibility Phase

MasterControl Supports Pharmaceutical / Biotechnical: Feasibility Phase with Effective Software Solutions

Once the arduous task of lead generation is completed to a satisfactory endpoint, reports are generated on the various compound innovations thought to be worthwhile products for the company. Decisions on which leads to advance to commercialization, either internally or through partnership, are based on inputs from several departments within the company, who globally monitors product relevance and market fit. In preparation for portfolio review discussions with senior management, departmental teams collaborate on potential product scenarios, risk assessments, market analyses, burn rates, and expected revenues. With product success and company revenues riding on the outcome of this collaborative process, accuracy is paramount. The pressure is further increased by the fact that, once patents are filed, the clock start ticking on the product's patent life.

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Pharmaceutical Feasibility Phase Software Solutions MasterControl Document MasterControl Collaboration MasterControl Out-of-the-Box Solutions
MasterControl Manage Documents in Biotechnical Feasibility Phase		Collaborative Workflows in the Pharmaceutical Feasibility Phase
Lead generation reports Market analysis on each qualified lead Financial statements on each qualified lead Manufacturing scenarios and expected costs Competitive landscape reports Patent filings Product commercial path scenarios IND submission strategy Regulatory strategic plan GLP documentation Toxicology, DMPK, and pharmacology reports Study templates Formulation development documents for manufacturing build-out		Research "Go/ No Go"; decision making: The scientific and business analyses that support lead candidacy are developed by the domain area teams. All information (including scientific lead reports, manufacturing feasibility reviews, regulatory strategy scenarios, clinical trial costs, as well as analyses of therapeutic markets, competitors, fiscal impact, and patents) must be melded into business strategy development reports and presentations to be reviewed by senior managers and the Board of Directors, who make the "go/ no"; decisions. Formulation development: Discovery research and manufacturing develop processes for chemical or biologic entities that must meet specific formulation criteria. This process may require several iterations and revisions to complete. Manufacturing continually evaluates the feasibility of various formulation trials to ensure that large scale production is attainable and will be cost effective. Business decisions:Competing technologies with similar therapeutic platforms are evaluated via the collaborative efforts of both business analysts and patent attorneys to ensure a competitive market advantage. To ensure accuracy, with respect to patent submissions and market analysis, discovery research is responsible for continuously providing the most up-to-date scientific information available. Clinical development: Internal and external physicians and scientists review the most current scientific data and use this information to determine the best course of action in initial clinical trial design scenarios. This collaborative effort involves the discovery research and regulatory teams as well. Documents are continuously revised and passed back and forth until the final leads are selected, at which point, the focus escalates to strategy development. Discovery research: Companies employ scientists, each with specific responsibilities within the chemistry and pharmacology discovery process, to develop new therapeutic compounds. These researchers are in continuous communication with one another and with the company on various aspects of the scientific study results.

Benefits of Document Control/ Management Software in Biotechnical Feasibility Phase

• Secure, centralized, virtual vaults provide effective document management of compound innovations, lead generation reports, and other documents created during this phase.
• A centralized document repository makes search and retrieval easy.
• It also makes it easy to retrieve documents during inspections and audits.
• Dual passwords, password expiration, and industry-standard encryption capabilities ensure secure communications between the web browser and application software.
• Documents being revised and passed back and forth between scientists and the cross-functional team during the clinical process reside in the “draft” vault while being worked on, and, once approved, automatically move to the "approved/ released"; vault.
• This prevents unauthorized documents from being accidentally approved/ released before the final lead therapeutic candidates have been selected.
• It also avoids duplicated effort; a document under revision can be locked to prevent multiple users from simultaneously making the same changes.
• And it makes it easy to locate a document associated with a particular drug candidate to determine its status.
• Automatic archiving and cataloguing of "outdated" scientific laboratory and formulation studies and reports provides a GxP-compliant audit trail.
• Reporting and analytics capabilities, including customizable reports and online charting, can be particularly useful during the decision-making process on pharmaceutical leads.
• Auto load capability enables users to drag-and-drop new documents into preconfigured network folders, making it easier to load documents into the system.
• Standard or customized reports in real time can be scheduled at regular intervals or requested at any time to keep authorized users, both inside and outside the company, up-to-date.
• System automates routing, delivery, escalation, and approval of documents and tasks.
• Provides electronic approval capabilities and signature manifestation required by the FDA.
• If necessary, escalates tasks to next level of responsibility to avoid bottlenecks.
• Provides the ability “to chunk data” for particular audiences or purposes to facilitate the collaborative effort.

Benefits of Pharmaceutical Feasibility Phase Collaboration Software

• Provides a web-based, virtual workspace for collaboration.
• Provides the ability to communicate effectively with the many individuals, both inside and outside the company, who are involved in report authoring and collaboration.
• Because the software is web-based, authorized users can access lead generation reports, manufacturing scenarios, competitive landscape reports, etc., from any location.
• Creates "system transparency" for authorized users, allowing them to see where a lead compound is in a workflow.

Biotechnical Feasibility Phase Software Solutions

MasterControl offers two out-the-box solutions to help companies collect, organize, and manage the documents necessary to meet all FDA submissions requirements.

• MasterControl GCPDocs Express™
• MasterControl GCPDocs JumpStart™

Contact Us for Pharmaceutical / Biotechnical: Feasibility Phase

For more information about Pharmaceutical Feasibility Phase and Biotechnical Feasibility Phase, feel free to Contact MasterConrol representative.