From pre-clinical into drug development with the same partner

PharmaRelations was working with this small Nordic Biotech company within several areas like QA, Regulatory and PharmaCovigilance in a pre-clinical phase. These services were provided by the Regulatory Services team that are highly specialized in this area. As the company was preparing to move into the drug development phase they needed new types of services and advice.

PharmaRelations Scientific Affairs offered their services to design a project for the next phase including a Clinical trials project and selection of a CRO company to conduct the Trials, with PharmaRelations overseeing and supervising the CRO-project as it started.

Benefits for the Client: The client saved time and money and reduced risk as they did not need to develop relationship and evaluate a new consulting company for the second phase, the contractual part was made much easier on the basis of an existing business relationship.

Pharmarelations Scientific Team supported the client with a full design of the trials and took on the task of writing the protocol. The sample size and the statistical analysis and part of the protocol was executed by the Scientific team. The Scientific team also undertook to produce the medical input including vital information about patient groups, prevalence and standards of care for the patient groups. The team defined the clinical sites for the trials.

The evaluation of CRO partner was made easy by the support the Scientific team and our oversight of the CRO project was of vital importance for the client that lacked such experience.