Datapharm Australia can extend your project internationally!
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Clinical Trial Management & Monitoring Statistical Analysis and Reporting Clinical Trial Management & Monitoring: All trials are monitored in accordance with ICH GCP. CRAs at Datapharm Australia have considerable clinical research expertise and broad therapeutic experience. Datapharm has a nationwide team of monitors allowing us to provide a cost effective solution to the trial sponsors reducing expensive travel costs. Datapharm Australia believes that monitoring is not only about making sure that the project runs smoothly with minimum protocol violations and low query rate but also about delivering personalized service. By having an empathy with people our CRAs are able to produce a dynamic rewarding and mutually beneficial site and sponsor relationship. Our monitors and project managers are actively involved in all aspects of clinical trial management: Protocol review Writing the patient information and informed consent CRF design Investigator selection Preliminary pre-study visits Assisting with site budgets and contracts Writing HREC applications and assist sites with submissions and responses to HREC Assist with regulatory submissions including CTN, CTX and GTRAP Coordinating investigator meetings Setting up monitoring plans, source data verification checklists and patient status tracking Site initiation visits Interim monitoring visits to sites and pharmacy Reporting to sponsor, newsletters to sites Assistance with recruitment issues Maintenance of trial master file (TMF) Organise, track and run site budgets for sponsor Close-out visits to sites Pharmacovigilance this service allows our medical personnel to log, track, provide advice to the sponsor and report SAEs to the appropriate regulatory authorities. Medical narratives, MedDRA code and reconciliation with the clinical database are included. It is particularly useful for new biotech companies that have no medical staff. Datapharm Australia's monitoring team is assisted by several technology solutions: eFFICE this is a web based management system for clinical trials based on a collaboration with Datapharm Australia Pty Ltd and Docbanq Pty Ltd ( www.docbanq.com ). It allows our regional monitors to share documents and files in a clinical trial specific, secure, online management system that provides a data trail and allow all trial electronic documents to be archived simply to an electronic TMF at the completion of the clinical study. eTMF allows for electronic archiving of the trial master file (TMF) Datapharm Australia has a particular niche as a CRO in the area of data management with an experienced team of data managers, clinical data associates, database designers and programmers. They recognize the importance of a smooth interface with CRAs, project managers, sponsor and site staff. Datapharm Australia ensures that the clinical data that is to be submitted to regulatory authorities is collected using validated systems that comply with ICH GCP and FDA CFR 21 Part 11. Datapharm Australia's many years of experience ensure that the data collection forms (CRFs) are designed to capture the data accurately and that a validated database is set up that complements the CRF. A data management plan (DMP) is set up for each project to describe the consistency checks that are run and Datapharm's trained clinical data associates issue clear concise data queries, identify protocol violations and ensure efficient database locks. A rigorous QC process with error analysis is also performed on all entered data. Datapharm Australia has a team of programmers to design the database and program the data listings and consistency checks in SAS. Data capture systems include double data entry from paper based CRFs into an FDA compliant database system, scan/fax forms, web based eCRF (www.lambdaplus.com) and PDA data collection using ePRO (www.symfo.com). Our trained coding specialists code the clinical data using standard coding dictionaries including MedDRA for the adverse events and medical history and WHO DD for the concomitant medications. All the data management processes are tracked electronically allowing regular updates on patient status, data receipt including missing segments or pages, data entry and verification, data query status and protocol deviations. Datapharm collects metrics on all projects allowing benchmarking across projects and continuing improvement in procedures. The phases of data management processes are logged as: set up data capture data management and validation analysis and reporting project management Statistical Analysis and Reporting Datapharm Australia covers all aspects of Statistics. Our team is committed to providing the highest quality services and always working together with the sponsor's goal in mind, flexibility remains a key priority. Statistical advice on study design Sample size calculations Statistical analysis plan (SAP) Randomisation code Statistical input at Clean File and on DSMBs Statistical analysis Data listings SAS programming and data sets Writing full study report (FSR), publications, IB, abstracts, presentations Full study reports are written, with appendices, according to the ICH-E3 guidelines Structure and Content of Clinical Study Report'. Our statisticians, project managers and medical advisers in-house assist with the medical writing. Our medical writers are available to assist with: Preparation of publications, abstracts, posters, presentations for investigators Writing protocols (including statistical section from statistics team) Investigator Brochures Full Study Reports |
