Success has many fathers. Drug development is complex. There are ups and downs. When things are going well, there are many fathers. Some will try to take credit for the success. However, when things go wrong, and they will, the failing team will be on their own. On the team, everyone will be pointing the finger at everyone else. That is where Speid & Associates can help.
Appeals are an important part of Speid & Associates offerings. We have the skill needed to refocus the team, and as a result we have a 100% success rate in Appeals. The team is already feeling bad about the rejected drug application or the clinical hold. When Speid & Associates is hired, we systematically look at why the team got the result it did, and then we systematically plot a path to success. Slowly, but surely, we begin to see success. That is used to turn the team’s mentality around. It works every time.
If you are in a hole stop digging!
It never ceases to amaze me that a company will get a rejection to their very expensive drug application. They will then retain the very same consultants that messed up their application. They will keep the internal team the same. Guess what? They get the same result. Often the drug is discarded. Think of all the patient hope that is also discarded. This was often avoidable.
No football / soccer team stays the same after a string of match losses. The team manager looks at the dynamics of the team and makes the necessary changes. He might sell a player that is not working as hard as he/she could. They use digital statistics and they know when a player is playing at 10% versus 100% capacity. If the player consistently gives only 10% effort, he will be sold to another team. Same should apply in drug development.
The project’s complexity and scope are other crucial considerations. Drug development consultancy can cover various tasks, from early-stage research to late-stage clinical trials. The advisors must possess the knowledge and resources necessary to address each stage’s unique requirements and difficulties. They must be able to modify their strategy and offer specialized solutions to satisfy the particular requirements of the project.
Are you on clinical hold? Give us a call. Has your drug application been rejected? Give us a call. For goodness sake, change your team.