Clinical Trial And Project Management
QUADRO CRO performs and handles project management for Clinical Trials, Observational Trials, and Compassionate Use Programs according to ICH GCP and applicable regulatory requirements.
We provide the following services for local or international studies:
- Site Feasibility and Selection
- Site Initiation
- Site Monitoring
- Site Close-out
- Inventory Keeping of Trial Supplies
- Planning and Coordination of Investigator Meetings
- Importation and Customs Procedures
- Trial-specific Training
- Site-specific Dossier Management
- SAE Surveillance and Collection
- Contract Negotiations with Laboratories
- Contract Negotiations with Rotating Fund Directorates.
Submissions To Ethics Committees And Ministry Of Health
To minimize the risk for revisions, we engage the Ministry of Health and Ethics Committees in preliminary discussions and report to Sponsors on requisites. QUADRO CRO strives to provide a top solution partner functioning to highest standards to add value for our clients and to ensure their satisfaction by taking the extra step for timelines and standards generally accepted in the sector for various processes, including making of submissions to Ethics Committees, obtaining approvals and securing necessary permissions and affirmations from the Ministry of Health according to applicable regulations.
The application timeline and the approval process is determined after the Sponsor completes trial documents.
QUADRO CRO has strategic partnerships with experienced medical writers who are experts in their respective fields.
We offer comprehensive, top-quality medical writing services, including:
- Trial Protocol Design and Writing
- Informed Consent Form Design
- Case Report Form Design
- Research / Questionnaire Design
- Study Final Report Writing
- Study Interim / Final Report Writing
- Preparing Abstracts and Articles for Publication
- Journal Abstracting and Article Translation
- Safety Reports
- Manuscript Writing
- Manuscript Translation
- Manuscript Review for Presentation
- Manuscript Review for Style and Scientific Content
- Manuscript Formatting for Specific Journals
- Abstract (Bulletin Summary) Preparation
- Abstract / Manuscript Submission
- Poster Preparation / Printing
QUADRO CRO’s services cover those in connection with pharmacovigilance studies.
These include scientific studies to detect, evaluate, identify and prevent adverse reactions and other potential issues associated with human medicinal products.
Pharmacovigilance is particularly focused on adverse drug reactions. To ensure the safety of patients, product safety data must be reliable. The active substance is the single most important element that impacts on the efficacy of a medicinal product which is the subject of pharmacovigilance.
For human medicinal products:
- adverse reactions occurring during routine use in a patient with one or more human medicinal products are reported SPONTANEOUSLY.
- These reports are made to TÜFAM by completing the “Adverse Reaction Report Form.”
QUADRO CRO collaborates with experts in the field for rendering Data Management services.
- Statistical Section Design of Trial Protocols
- Calculating Trial Sample Size
- Statistical Analysis Planning
- Statistical Data Analysis
- Interim and Final Analyses
- Data Management
- Database Creation
- Handling Duplicate Entries
- Creating and Handling Queries
QUADRO CRO provides Sponsors with personnel for various posts, including CRAs, Field Associates etc.
- Personnel selection is made after necessary searches are completed to identify suitable candidates according to the specifications and timelines as agreed with the sponsor (e.g., a biologist, chemists, pharmacist, nurse)
- Candidates for a position are interviewed, and CVs of eligible ones are forwarded to the Sponsor for approval, or personnel selection may be fully undertaken by us, depending on the agreement with the sponsor. Personnel may be employed half- or full-time, based on the sponsor’s requirements.
- Recruits are provided with ICH/GCP training, together with basic training according to a predefined plan and timeline.
- Training provided include role descriptions as relevant to Ethics Committees, Clinical Trials Regulation, Serious Adverse Events, SUSARs, INs and site processes.
- Upon the request of Sponsor, all personnel may be monitored in real-time using a web-based application, enabling instant personnel reports.
- Roles and responsibilities of Field Associates employed by our company are determined by the related legal guidelines.