CLINICAL OPERATIONS

Clinical Project Management

Key to the success of a full-service project is the Project Manager. The project manager will break down the project goals and scope into deliverable components, compile a project plan and associated documentation and oversee the work of the project team to ensure the timely delivery of project-specific milestones.  The project manager will be the main contact for our client and will provide routine project updates on study progress.

 It is our experience that a strong scientific background with passion for detail orientation and critical reviewing are mandatory skills in order to deliver a world class proof-of-concept study. Thus, for such early clinical stage projects, we recruit the Project Manager from our pool of Clinical Research Scientists. Other skillsets are more relevant for managing classical ‘large-scale, big pharma, phase 3 trials’, e.g. the ability to obtain results through management of larger group of people and systems, whereas the scientific background is of lesser importance.

Project management activities are divided into three phases, start-up, maintenance and closeout. The specific activities undertaken during each phase will change in emphasis as the project develops. All project management activities will be conducted in accordance with the SMERUD SYSTEM as detailed in a dedicated SOP . The PM is responsible for the coordination and management of all activities to ensure delivery of the project in accordance with the specifications agreed with the client.

ICH-GCP quality standards

Strict compliance with ICH-GCP is key to our operations. Our QMS is fully compliant with ICH-GCP R2. A complete set of SOPs is available to cover all aspects of ICH-GCP. Our staff receives a full GCP refresher training every two years and is trained on the GCP compliant SOPs to ensure that all our work is conducted in accordance with GCP. Further, our clinical research associates (CRAs) ensure that site staff are properly trained on GCP and that the site activities are GCP compliant. Work performed by the site (incl. GCP compliance) is continuously monitored by the CRA. Work performed by SMERUD project staff (incl. GCP compliance) is supervised by a SMERUD project manager. In addition to the hands-on, project specific follow-up, compliance is monitored by internal audits.

Feasibility analyses

A feasibility survey is performed to identify and select potential investigators/sites for participation in the study. As part of this process, the SMERUD collective corporate experience is reviewed with regard to similar clinical trials conducted before, and our experience with participating investigators and sites. In addition, we perform literature review and structured searches in clinical trial databases to identify investigators active in the relevant therapeutic area. From these activities a comprehensive list of potential investigator sites is developed. 

 A study-specific feasibility survey form is then developed for submission to the potential investigators.  A list of criteria for rating potential site performance such as ability to enroll target population, adequately trained staff, access to specialized equipment, involvement in other clinical studies etc. is developed. Following receipt of the responses to the feasibility survey from potential investigators, an analysis is performed resulting in a feasibility study report, encompassing a priority list of investigators for review with our client.

 Pre-study visits (site selection visits) may be a part of the feasibility study, and/or be conducted following a short-listing of potential investigators.

 

 

Activities within the SMERUD SYSTEM

  • overall coordination of functional service groups 
  • key study document development 
  • selection of central or local laboratories incl Agreements
  • clinical trial applications to competent authorities and ethics committees
  • clinical trial supplies inventory, including study medication,
  • subject recruitment status
  • oversight of site management and monitoring incl. review and sign-off of monitoring visit reports
  • project finances, incl. coordination and processing of investigator fee payments
  • ensuring acceptable quality standards throughout the project
  • tracking and management of key milestones and deliverables
  • meetings (preparation, conduct and minutes)
  • communication
  • Trial Master File set-up and maintenance

    Site management

    Our CRAs are the main communication line between study management and the site personnel and investigators. In order to proactively foresee and prevent any essential issues, the CRA remains in close contact with the site during the active clinical phase of the study (from Site Initiation to Site Closure). We believe in personal contacts through e-mails, virtual meetings but above all face-to-face meetings.

     Site management activities include:

    • Pre-Study Visit
    • Site Initiation Visit
    • Site Monitoring Visit
    • Site Close-Out Visit
    • Regular communication and status reporting 
    • Investigator Site File  set-up /maintenance
    • Collection of GCP documents
    • Study Medication management, incl. accountability and reconciliation
    • Oversight of patient recruitment and retainment
    • Identify and mitigate any risks related to study performance at site
    • Training of site personnel in GCP and study-specific procedures
    • Verify that the site allocates proper resourcing to the study

    Monitoring

    Monitoring a clinical study is in the DNA of SMERUD, as this has been a core service from the very start of our business. This service includes in-house (remote) monitoring, on-site monitoring (and source data verification, SDV) and risk-based monitoring (RBM). Our CRAs are routinely trained and retrained in basic and advanced GCP and associated regulations. They will conduct their monitoring diligently and with particular attention to details and high quality of the captured data according to a Core Monitoring Manual. With a focus on early stage clinical trials, SMERUD’s monitoring is particularly wary about safety issue detection and reporting as well as early signals of possible efficacy. The CRA collaborate very closely with colleagues in our Data Management and Pharmacovigilance/Medical Monitoring units.

     On-site monitoring visits will be supported by in-between remote (in-house) monitoring of study data. In addition to pre-defined electronic checks, the SMERUD CRAs and Data Managers collectively perform manual inspections of key data in the eCRF. In this way, our ambition is to detect early any quality issues so that the site can be pre-alerted, and that our on-site visits can be conducted more efficiently.

     

     

    Risk-based monitoring

    According to our SMERUD SYSTEM, we approach each clinical trial with a specific risk-based monitoring plan. Data from cross-departmental operations will be assessed on an integrated level, and discussed within the study team so that appropriate measures can be undertaken. Relevant metrics coming from the site monitoring, data management as well as medical monitoring together provides us with relevant insight, so that revised monitoring actions and focus may be implemented.

     Key elements in our RBM decision making are:

    • Data quality
    • Patient enrolment status
    • Screen failures
    • Protocol deviations
    • Adverse event reporting differences
    • Patient withdrawal rates
    • Site staff turnover
    • Site resource availability
    • Site experience
    • Site’s data entry timeliness
    • Data query resolution timeliness and quality
    • Blinded data variability differences
    • Data outliers
    • Safety signals