Development Log Module

The Development Log is a software functionality that provides a data warehouse to help manage all aspects of a drug development project. It allows a user to collect data, create process description, record batch data, and organize it into interactive data display screens and reports. It can be the single repository where data can be stored and managed in an intelligent way and where users can dynamically interact with data in new ways.

The Development Log can also be used to maintain the project status, history and milestones, API Processes, Formulation Processes, Analytical Methods and Results, Chemistry, Manufacturing & Controls Regulatory Submissions. Users of the application will be project managers, company management, and technical experts within the company.


Key Features


  • Web-based (server-based optional) enables data entry across the organization and the supply chain (CRO, CMO).
  • Intuitive user interface to easily input and mine drug development data and provide unique reports.
  • Fully Relational Database – records and relates data associated with individual programs or active ingredients. Data is captured for processes used and all formulations associated with the compound.
  • Stores structured and unstructured data including documents and JPEG images.
  • Offers data entry via the U/I or standard bulk loading tools.
  • Built using commercial software development database technology (MS.Net and SQL Server).
  • Scalability – easily supports large and small enterprises.
  • Extensible – easily accommodates new capabilities and configuration specific to your process through Rondaxe Professional Services.
  • Interoperable – system architecture integrates easily with other third-party applications you may use.
  • Role-based Security – defines which users have access and to what information across your organization and even extending out to your consultants, CRO or CMO.
  • Audit Tracking – records time stamp and offers audit trail of data entry.
  • Database Integrity – once dependencies and associations are made between batches or synthetic routes, certain attribute fields are ?locked? to prevent inadvertent changes and loss of data integrity.

Key Benefits


  • developath® – serves as an interactive guide to users providing key milestones in development, manufacturing and marketing through API selection to clinical trials and commercialization.
  • No Cost of Ownership – is available as a hosted application, which means there’s no need to acquire computer hardware, software or for internal IT resources.
  • Share Information Across the Organization or Enterprise – information can be accessed and organized by steps in the development process, functional group (manufacturing, finance, supply chain, etc.), or type of records (batch, analytics, etc.)
  • Share Information Across the Supply Chain – that can include third parties such as consultants, CRO, CMO who can work more efficiently and may benefit from access to the development data, or who may be creating data that should be captured and recorded just like an internal user. Role-based permissions and security eliminates risk.
  • Data Entry – You can do it, or we can do it for you. The application interface offers easy ways to enter individual or multiple data records. For organizations that historically have only maintained their data on paper or in electronic documents, entering data in the Development Log may be a barrier. Rondaxe has a knowledgeable staff that can review your documents and populate your historical data. Moving forward we can continue to support you in this process or you can begin to enter your data on your own.
  • Available as a Server Model – mid to large sized companies that have already invested in an IT infrastructure and resources can license the Development Log and deploy it on their own network and leverage their existing IT infrastructure and resources.
  • Integrate and Extend – the Development Log is commercial grade, standards-based technology built using Microsoft development tools (.NET 3.0) and MS SQL Server. It can easily integrate with existing applications that house data involved in the development process. It can also be enhanced or configured to meet specific needs of your process or business.