The clinical trial protocol is a vital reference document for use by all participating study personnel.
At Java, we understand how important it is that clinical study protocols describe all relevant information required to conduct the study uniformly and to the highest standards. It is also essential that protocols are written with clarity and specificity.
The team at Java has considerable experience in developing and writing clinical research protocols in accordance with ICH/GCP guidelines and other applicable regulatory requirements. Every protocol is developed in collaboration with the Sponsor in order to ensure that the Sponsor requirements and objectives are being addressed. We also address the needs of protocol end-users, such as clinical investigators, site nurses and other staff.
The development of this document is central to the success of the trial and our expertise in this field is second to none. Contact Java to learn more.