Off-Track Study Solution

Important projects do run into snags and complications that will interfere with expectations. The delays can be extremely costly, triggering a series of investors’ questions, not to mention hype from the press covering your company’s activity. You start to see the formation of the black cloud that you wonder why or how this was allowed to happen.

In cases pertaining to clinical studies and New Drug Application submissions, there are events in your project plan that cause these delays such as having data issues, high turnover of programming resources and simply said, inexperienced staffing that haven’t had previous exposure to being part of a submission to the FDA and/or don’t have problem-solving experience.

A rescue team is hired to save a project from derailing further and putting it back on track. The goal of a rescue team is also to save the company’s reputation. This is easier said than done and a colossal task to take on. The rescue team will usually need to backtrack to where the initial problem(s) began to occur and to resolve the issue before moving forward. Resuming on a high frequency track cannot begin if the core problems aren’t addressed.

The process of selecting a rescue team requires one to be meticulous. You need to look for extremely qualified and experienced resources. Everything the rescue team acts on needs to be efficient and with minimal interruption. Hiring programmers with an average of 19 years experience is a positive move as they are self-starters and require minimal oversight. They understand the goal and have years of experience allowing them to dig in and get the job done.

Those experienced, who have been project managers, have problem solving experience. This is your “A” team. Not everyone will have this strong a team together under one umbrella unless the group you are speaking with has a record for high programmer retention over a significant period of years. Look for teams that have at least 90% retention year after year.

Team members should be programmers with a diverse background so there is less need for explanations. This will ensure the team is moving along at the speed necessary to get back on track.

Teams that have been together for at least 5 but more likely 10 years or more will have the core strength to know what problems look like and how they begin. Perhaps finding an experienced team that worked in QC and Validation is a good way to go.

Going to the right resource for a strong pool of rescue project workers is also very important. A Functional Service Provider (FSP) that is an expert in clinical programming and FDA submissions is the first step one should take. The organization will have experienced Project Managers and the team members will be ready to go. They are self-starters and will bring the right tools to get the job done. The FSP owners are laser-focused on the project as well. They understand the mission of the A Team and will provide all the backing necessary to help their team put your project back on the tracks. Programming is their business so an understanding of the issue and mission is readily addressed without their attention being pulled to another functional service.