Adhesion Disease

Case Study:

Phase III Clinical Trial (Post-Surgical Adhesion Disease)

Therapeutic Area:

Post-Surgical Conditions – Adhesion Disease

Study Phase:

Phase III | International | Full-Service CRO Support

Background:

The investigational product is a novel therapy developed for use after surgical interventions for the prevention and treatment of post-surgical adhesion disease. At the time of the study, the product represented an innovative approach in an area with limited therapeutic options. Following successful clinical development, the drug has been launched in EAEU.

The therapy is administered in the post-operative setting and requires close clinical oversight, coordination with surgical teams, and careful management of patients during recovery. The sponsor engaged Smooth Drug Development as a full-service CRO to support this complex Phase III clinical program in the EAEU region.

Client Challenge:

The Phase III study presented significant operational challenges due to its post-surgical design and novel mechanism in this therapeutic area. Only a limited number of surgical centers had both the required expertise in managing adhesion disease and prior experience in conducting clinical trials, which constrained site selection and enrollment capacity. In addition, the study involved complex protocol requirements that required tight coordination between surgical teams and research staff.

Smooth Drug Development Full-Service Solution:

Smooth Drug Development provided end-to-end clinical trial support, including:

• Medical and study-level documentation

• Identification and qualification of experienced surgical trial sites

• Site activation and monitoring with a focus on post-surgical workflows

• Ongoing operational oversight and risk management

Study Scope & Timeline:

• Multi-center Phase III clinical trial

• Patient population: Patients undergoing open abdominal surgeries, including reoperations, excluding surgeries for adhesive disease or purulent peritonitis

• Planned number of patients to enroll: 480 patients

• Number of approved sites: 48

• Number of actively enrolling sites: 27

• Enrollment completed within 11 months

• Conducted at specialized surgical sites with prior clinical trial experience in adhesion-related conditions

Key Challenges:

• Limited number of surgery centers experienced in both adhesion disease management and clinical research

• Need to align surgical procedures with protocol-specific study requirements

• Restrictive eligibility criteria impacting enrollment

• Requirement for protocol amendments to optimize recruitment while preserving scientific rigor

Proactive CRO-Led Approach:

Smooth Drug Development implemented a structured, solution-oriented approach:

• Identified and activated qualified surgical sites with proven research capabilities

• Provided targeted training for surgical and site staff on protocol and GCP requirements

• Supported protocol amendment planning and regulatory implementation

• Coordinated closely with sites to integrate study procedures into surgical workflows

• Maintained close oversight to minimize disruption to enrollment and timelines

Results & Outcomes:

• Successful execution of a complex post-surgical Phase III clinical trial in adhesion disease

• Enrollment completed within planned timelines despite site limitations

• Sufficient number of study completers achieved to support robust statistical analysis

• Full regulatory and GCP compliance maintained throughout the study

• High-quality clinical data generated for novel therapy

• Contribution to the successful market launch of a first-in-class treatment option for adhesion disease in Russia

Impact:

This study demonstrates Smooth Drug Development’s ability to manage novel drug development programs in complex post-surgical indications. The project highlights Smooth Drug Development’s expertise in supporting innovative therapies from late-stage clinical development through market launch, even in therapeutic areas with limited precedent and high operational complexity.