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Pre-Clinical Management Case Scenario

The following case scenario illustrates the complexity of the drug development process. Each step in the process noted below is numbered within parenthesis. This is a scenario only, and not meant to be a complete overview of the entire drug development process.

Scenario. During a steering committee on a new drug, Greg Hammond, the drug product sponsor for a drug company, has been given the assignment to start work on a promising drug compound to see if it can be developed into a viable product.

The Process. Greg’s work needs to be organized. He’ll need to identify the studies to be done (1) and the directors who will be participating (2).

He has established a team of study directors. Now, his job is to maintain oversight of the project (3). It’s important that he has the ability to track the activities of each of his directors (4) and their teams (5), as well as manage the budget (6).

Greg is also the gate keeper. He will be involved in reviewing all documents (7), and registering approvals (8).

One of the study directors involved is Steve Fischer. Steve has received notification of the new projects that he will manage. Now that Steve has entered the project, his work must be tracked.In order to complete these projects, he’ll need to find the right resources (9). To build out his team, he draws from a personnel resource pool (10) – looking for the qualifications he needs for each job. The studies he will conduct (11) are pre-built from industry standard templates, though he can make adjustments as needed.

One of the roles that Steve seeks is that of a Medical writer (12). In this case, Maggie Smith receives an email notification and work request list (13). Now Maggie’s work will be tracked. As the work progresses, Maggie replies back to the project manager, and any other party, on the status of her part of the project (14). This information can be communicated as a note or provided as a status update. She can communicate a proposed timeline and record efforts on a check list (15). She can also upload documents (16), which may, or may not be stored with other study documents. Maggie indicates what she is working on and communicates back to the project manager (17). Once Maggie’s portion of the project has been approved (18) by the project manager, the medical monitor is notified and can either give the document approval, or send it back for revisions (19). If the document is approved, it then goes back up to Steve Fischer (20), for his approval. Maggie can then draft the protocol (21) and write a synopsis (22). This work then goes through another approval (23) and is then sent up to Greg Hammond (24).

The problem. Each of the steps reported above is a risk to the work process. And these 24 steps represent only part of the picture. Many more individuals and teams are involved in the drug development process, compounding the risks to the organization. Communications can break down and handoffs may be incomplete. If there is a road block in the process, it may be some time before the appropriate manager is aware of the problem. Individuals may store documents in different areas, leading to an unorganized archive and the likelihood of missing documents. In addition, changes to timelines and schedules may not be communicated to every individual. These problems result in delays, cost overruns and budget concerns.

The solution. DLTA provides a structured approach throughout the enterprise. DLTA’s interface works with all platforms, providing a single solution to manage each step of development. DLTA also automates the process so that timelines, schedules and responsibilities are tracked. The sponsor has complete visibility with all tasks, ensuring that priorities are met. And with DLTA, there is one place for the data, documents and communications for the entire team.

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