As a CRO our company provides a full range of clinical research services. Our primary focus on the Romanian market are Phase IV/Post-marketing studies, where we have extensive experience in providing end-to-end services, from planning and regulatory to pharmacovigilance, biostatics and medical writing. We have developed our own SOPs for ensuring high and consistent quality standards throughout the sponsors’ projects. Favored by the flat organizational structure, the processes we have in place facilitate strong communication within the team, with the on-site study staff, and with the sponsor, quick decision-making and flexibility. Our uncompromising ethical and quality oriented culture, the competence in many therapeutic areas while consistently meeting budgets and timelines are valued by our customers and reflected by the high level of repeat business with them. Our senior management is continuously involved in all stages of the projects, promoting and sustaining a culture of commitment and responsibility across our team.
We have a strong track-record in providing high quality and cost effective site management services, and this is one of our key differentiators vs. other CRO’s on the Romanian market.
We have a strong track-record in providing high quality and cost effective site management services, and this is one of our key differentiators vs. other CRO’s on the Romanian market. Qualifying sites was a continuous area of attention for us over time, therefore we know and can recommend the most effective sites over the country in terms of rapidity of start, enrollment rate performance, staff responsivity and effectiveness etc. Our site managers are located in several regional hubs country-wide, thus ensuring long-standing relationships with Investigators, high reaction speed, and costs minimization. We developed dedicated site management SOP’s, revised and up-dated periodically, thus offering a consistent and sustainable basis for high quality clinical data output to our sponsors.
WHY SITE MANAGEMENT?
- Study teams are usually understaffed and/or they conduct several studies at the same time. Therefore, in most cases, investigators need additional support
- Administrative aspects are often perceived by investigators as the most unpleasant part of the study and therefore treated with less attention
- CRFs and other documents completion is seen as time consuming and often postponed or done with errors if done by the study staff
- In audits or inspections, many findings are caused by insufficient attention to details and lack of time for quality control
WHAT DO WE PROVIDE?
- Site initiation and close-out procedures
- Support for patient selection and eligibility assessment (e.g. review of hospital charts & patients database, training site staff as required)
- Ensure updating and completeness of the Site Management File (SMF)
- Ensure protocol accuracy and compliance
- Periodic check and support for correct and timely completion of source documents
- Data entry on CRF/eCRF and/or assisting investigators in completing documentation
- Patient scheduling for visits on site, laboratory tests and/or other investigations
- Support site staff with safety reporting, query answers and corrective actions
- Site preparation for monitoring visits, audits and/or inspections
- Report adverse events and advise investigators about potential protocol deviations and/or regulatory problems
We offer end to end comprehensive clinical data management services, from developing the Data Management Plan to data archiving, while using our own controlled and secure computing environment.
We offer end to end comprehensive clinical data management services, from developing the Data Management Plan to data archiving, while using our own controlled and secure computing environment. Our staff, processes and technology ensure the delivery of accurate, complete and reliable clinical data for analysis and decision-making.
WHAT DO WE PROVIDE?
- Data Management Plan (DMP) development
- CRF/eCRF design, development, completion guidelines
- Database design and implementation
- Data cleaning, validation, and quality assurance
- Electronic Data Capture (EDC)
- Edit checks programming & testing
- Double Independent Data Entry for paper-based CRF
- Safety Data Management & Reconciliation
- Data Backup and Archival
- Disaster Recovery Site
- Project Management
Our team of biostatisticians provide their experience and extensive knowledge of statistical methodology in all aspects and phases of clinical studies.
Our team of biostatisticians provide their experience and extensive knowledge of statistical methodology in all aspects and phases of clinical studies. Delivering high-quality and accurate data analysis, we determine in compliance with regulatory guidelines the best methods for collecting, analyzing and presenting your data. We offer our clients access to data in the best-suited formats to project requirements. We offer statistical support and services in the following areas:
- Study Design: Proof of concept or dose-finding; Superiority/Non-inferiority/Bioequivalence; Flexible designs
- Basic, interim and/or final statistical analysis reports
- Quality control of layout and deliverables (tables, charts, pictures etc.)
- On-going statistical advice throughout the study
- Statistical input into Study Protocol/Observational Plan
- Sample Size Estimation
- Statistical Analysis Plan, Table Plan, Table Shells and Analysis Dataset Specifications
- Analysis and Reporting
We have an experienced and skilled team of medical writers which can handle clinical trial related documents, as well as medical writing of abstracts and scientific papers.
We have an experienced and skilled team of medical writers which can handle clinical trial related documents, as well as medical writing of abstracts and scientific papers. Here too, our dedication to quality doubled by flexibility and responsivity are much appreciated by our clients. Documents are reviewed in a multistage approach and we collaborate with subject matter experts to ensure an end product of the highest quality. In the area of scientific papers and presentations we have a track-record of successful submissions to large international congresses and conferences for our clients, covering various therapeutic areas.
ROOF-READING AND MEDICAL WRITING OF ABSTRACTS AND SCIENTIFIC PAPERS
- Professional proof-reading and medical writing of abstracts and scientific papers for publication in peer-reviewed medical journals and/or presentations for congresses/conferences (Romanian and English language)
- Power point supporting material for oral presentations
- Posters for medical events and/or specialist fairs/exhibitions/conferences
PROFESSIONAL WRITING OF CLINICAL TRIAL DOCUMENTS
- Development of study protocols, clinical study reports, patient informed consent forms, investigators brochures for non-interventional and epidemiology projects, compliant with client/sponsor guidelines, our own SOP’s, and ICH GCP/EMA standards and regulations
What Our Clients Say
“Target Consulting Group is very responsive and adapts well to changing circumstances. This company always delivers high quality results on time, and we are impressed …”
– Medical Director
“Target Consulting Group is very responsive and adapts well to changing circumstances. This company always delivers high quality results on time, and we are impressed with their carefully considered, creative input into our clinical trials. In particular, we appreciate the high level of customer service and high quality work provided by their competent and professional team. Target Consulting Group demonstrates commitment to timelines above and beyond the call of duty” – Medical Director
“TCG has comprehensive experience across a variety of therapeutic areas and health care disciplines, stimulating creative thinking and different approaches to current challenges. The strategic alliances established by TCG enhance these core strengths to add further value and synergy. They always delivered best results for our projects, in a timely, highly professional manner” – Clinical Studies Director
“TCG employs a team of highly qualified professional staff with significant experience in the areas of medicine, regulatory affairs, clinical research, data management, biostatistics, health economics, pharmacy, nursing, disease management, sales, marketing, medical information and information technology. This unique integration of diverse skills, expertise and qualifications, separates this SMO from competitors. They are very professional, reliable and supportive“ – Head of Medical Department
“TCG is dedicated to patient safety and effective care interventions through novel and existing pharmaceutical products and medical devices. This SMO provides a holistic, goal oriented approach to clinical trial management. Their work added value to our business and is likely to contribute to successful and timely completion of future projects and collaborations” – Manager Clinical Studies