Effective management of clinical studies is critical for ensuring study completion on-time and within budget. Challenges may include slow enrolment or underperforming sites, management of geographically distant team members, ensuring regulatory compliance, budget control, selection of suitable study sites and meeting study milestones. The DLC Clinical Project Management process is based on effective planning, communication and budget control, combined with extensive regulatory knowledge.
DLC study management philosophy is centered on the development of Study Management Plans, which address the key good clinical practice (GCP) compliance issues related to the clinical study and establish defined roles, responsibilities and contingency plans for key study activities.