Clinical study monitoring

BELTAS offers experienced Clinical Research Associates (CRA's) to monitor and manage clinical trials. Initiation, monitoring and close out visits are run according to sponsors' requirements and reporting methods, documented in the Clinical Monitoring Plan. Our experience ranges from outpatient trials to complex inpatient trials, and across a range of organisations and therapeutic areas.

Staff training includes Good Clinical Practice (ICH-GCP), Standard Operating Procedures (SOP's), technology, scientific & medical topics, and updates on industry developments.

Our CRA's work closely with sites to collect clean data quickly. All studies have a lead CRA and a back-up. Clear SOP's, responsibilities and good communications ensure consistency in working processes across the clinical trial CRA team.

Medical Monitoring

Medical monitoring is achieved through partnership with highly experienced local experts specialised in this area. BELTAS does not retain staff medical monitors.

Site Monitoring

BELTAS provides monitoring of clinical trials. At each monitoring visit, according to project scope, CRA's review:

• Protocol compliance
• Case Report Form (CRF) accuracy and completeness
• Serious Adverse Event (SAE) reporting to the required bodies
• Tracking of mandatory reporting to Ethics (IRB) & Regulatory authorities
• Enrolment & suitability of participants
• Trial progress & review of strategy
• Continued acceptability of investigator and facilities
• Filing and maintenance of source documents
• Investigational Product inventory and accountability records
• Compliance of investigator's document file
• Collection of data for interim analysis

Following each site visit, BELTAS prepares a monitoring report in accordance with BELTAS or sponsor SOP’s as specified.

Communications

BELTAS works significantly with sponsors based overseas, and often with sites across multiple regions. This makes communications, not only formal reports, but informal updates, critical. The company and staff members have received considerable positive feedback on the quality of its communications. See Case Studies for examples.

BELTAS organises document translations where required.

Reporting, Filing & Archiving

Formal reporting, correspondence, filing and archiving are an important part of clinical trial work. BELTAS takes these responsibilities seriously, to report clearly and accurately within the specified timeframe and to keep records in compliance with sponsor and regulatory requirements.

Site & Study Close-Out

At the conclusion of the study, final data needs to be gathered, investigational products accounted for, and any outstanding issues resolved with sites, both for the benefit of the study and for future involvement of the site in further studies. At this time, BELTAS CRA's:

• Ensure that Case Report Forms (CRF’s) and any queries or addenda are collected
• Complete an inventory of investigational product supplies
• Reconcile accountability and distribution forms
• Review all relevant documentation
• Return investigational product supplies or destroy as required
• Give final instructions to sites’ investigators and personnel
• Ensure final reports and notifications go to Ethics & Regulatory authorities

BELTAS works closely with the sponsor during this process to ensure all data for the study is collected and reported, compliance with regulatory authorities and ethics requirements are met, and loose ends (if any), are tidied up for stakeholders.

"Patient recruitment consumes more time than any other clinical trial activity, with thirty per cent of clinical trial time spent finding and enrolling study subjects"

- Cutting Edge Information