There are different challenges and pain points in clinical research industry and these can be helpful for some to know who wants to be in clinical industry. Top pain points of clinical industry are given as below:
- Patient recruitment:
Recruiting patient is the most difficult task and mostly there are no patients. So, having those tactics to recruit more patients can help to pass out your interview and get your foot in clinical industry.
- On time delivery:
On time delivery of the study is important which depends upon the phase of the project and it should be delivered on time to the sponsors so they can submit it to the FDA for approval. On time delivery can be difficult and can be a pain point because of the high turnover of CRAs and constant change of positions. Sponsor expectation can be a pain point because study can take more time than their expectations.
- Study startup:
Study startup process can be difficult, challenging and can take much longer to start clinical trials. It’s a part of startup process to get the signs of project investigator on the documents and to train the protocols, recruiting sites that are willing to accept the protocols and are able to recruit patients and have enough personnel and infrastructure for the trials which can take time.
- Ensuring compliance:
Ensuring compliance of the protocols can be difficult and can be a pain point in clinical industry. It is difficult especially when CRA turnover is very high and there are always new people to train about the studies and about all the protocols. Ensuring agreements and protocols can be difficult just because of the turnovers.
- Sponsor CRO communication:
Sponsor CRO communication can be slow depending upon the sponsor. Within the CRO there are many levels for communication as you have to go to the clinical trial lead who then has to go to the project manager who has to go to the project director and then project director goes to the sponsor and then the sponsor responds. Sponsor CRO communication can be a pain point because you have to go through certain levels to get the answer for few questions. This could be difficult and confusing because everyone thinks differently and the answer coming back can be completely different when coming back from a long chain.
- Data accuracy:
The purpose of having data management departments, visits of CRAs to sites and having experienced study coordinators is to collect accurate data. Note to files and nurses can be a problem in data accuracy. Having well paid and experienced CRAs who are monitoring well can be a solution to this problem.