Bridging studies are conducted with a few specific objectives in mind. One of the primary purpose is to avoid the undue replication and duplication of previously conducted clinical trials. Entire developmental structures have been conceptualised and conducted in the past but due to lack of cohesive knowledge and communication gaps the entire process has been repeated causing monetary and intellectual loss. Another purpose of such studies is to build solid bridges between completed research work and variable local factors.

Importance of choosing correct organisation for Japanese Bridging Studies

Wrong recruitment of organisation that conducts clinical trials have resulted in failure to adhere to delivery timelines and magnified research and development costs. Pharma companies have now woken up to the fact that they must choose third party vendors for their bridging studies carefully.

The culture of the clinical research organisation must be appropriate as the staff working there needs to undergo very specific kinds of training. The population that enters the organisation for these trials is generally foreign and will suffer from culture shock unless the  staff make it a point to make them feel comfortable. There must be a smooth cultural homogeneity starting from the fpoc (first point of contact) to the researchers actually involved in the trail. Learn more about Japanese Bridging Studies here >

Excellent track records

There cannot be too much stress on the importance of a spotless track record when it comes to choosing a CRO organization. Simply verify how a bridging studies organisation has responded to client expectations in the past and how well it has adapted to the changing trends in technology.

Adaptability to a dynamic environment is necessary for survival in the fiercely competitive Pharma world. It’s advantageous to hire an organisation which possesses its own in house talent management team.

Safety and care records

Bridging studies and clinical trial conduction requires adherence to very specific standards of healthcare and precautionary measures. Participants who are a part of clinical trial ventures know that they will be subjugated to some degree of risk.

However the standards of care and support extended to such participants by a CRO company is critically important. Good Clinical Research organisations which have their own in house team who constantly scan and monitor the progress of CRO participants are at a distinctively better position.

Good recruitment team

Infrastructure, track records and care standards are all critical elements of differentiation which separate the great CRO firms from the average ones. Another specific skill is recruitment knowledge as these companies need to get respondents who will willingly participate in their clinical trial programme. A solid understanding of the recruitment process, market knowledge, knowing how to pitch the project and then quickly scanning the group to select the most suitable respondents is key steps.

The sponsoring company should hire a CRO organisation which can show proof of its recruitment prowess and people handling skills. Putting together lucrative yet ethically correct advertisement material is something that not every CRO organisation can do.

Author BIO

Judith Gray is a pharmacology expert and author of numerous research articles at www.bridgingstudies.com with years of experience in SAD, Bridging and MAD studies.