Qualitix offers cost-effective contract research organization (CRO) services to support various aspects of new drug development and clinical trials. We work with our clients in a strict confidential manner. Our CRO services and confidentiality agreement will be tailor-made to fit your needs and to eliminate concerns of all kinds. In accordance with the guidelines, Qualitix provides a full range of services including:
The purpose of a feasibility study is to assist the research team to evaluate a protocol or concept sheet, thus allowing the decision making regarding the feasibility of the study. Our feasibility team works with the qualified personnel to distribute and collect confidentiality agreements and investigator-reported feedback.
Pre-study Selection Visit
Meet with potential investigators and assess their competencies; inspect facilities; discuss the protocols and schedule of events; determine potential of investigators regarding recruitment of sufficient number of patients in a timely manner.
Protocol Development
Qualitix works with medical consultants, in collaboration with sponsors and investigators to design and complete the protocol in accordance with ICH GCP guidelines.
Case Report Form (CRF) Development
According to the protocol, design efficient, concise, and user-friendly CRF.
Informed Consent Form (ICF) Design
Design protocol specific inform consent form based upon ICH-GCP guidelines, regulatory, IRB/EC and, sponsor/institutional requirements.
IRB/EC Submission/Approval
According to IRB/EC requirements, prepare and submit related materials and respond to all the questions raised by reviewers.
DOH Submission/Approval
According to the requirements of the DOH, prepare and submit required materials and respond to all questions raised by reviewers.
Study Drug packaging and labeling
Qualitix shall assign personnel to prepare the drug label according to the photocopy of random code and ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labeled in a manner that protects the blinding, if applicable. Qualitix shall package investigated drugs to prevent contamination and unacceptable deterioration during transport and storage.
Random code generation
Qualitix shall perform a permuted-block randomization and make emergent unblended envelope and keep it in the locked cabinet in the study site for emergent use.
Hold investigators meetings regularly with sponsors to facilitate the progress of the trial and to ensure the consistency and quality of the study.
Study Coordinator Training Course
ualitix will be responsible for the entire arrangement of study coordinator training course, including the presentation and related material preparation.
Site initiation
Qualitix shall assist Sponsor to supply the investigators with the investigational products and all special requirements for conducting trial. Training of all relevant site personnel will occur at this visit and an ongoing basis throughout the trial.
Clinical Monitoring
Routinely monitor the process of the clinical trial to ensure adherence to the protocol and GCP compliance and to validate data collected in CRFs versus source documents.
Project Management
Our project management processes in a clinical trial, though the application and integration of concepts of planning, initiating, executing, monitoring and controlling and closing. The clinical trial will be managed and conducted in accordance with ICH-GCP, applicable regulatory requirement, and approved protocol.
Strictly control the quality of clinical trials and make sure the clinical trial to follow the protocol. Report the work schedule to the sponsor at scheduled timetable. Cooperate with the sponsor and PI in the clinical trial and the related matters.
Audit of Clinical Trials
Provide sponsors and investigators routine quality assurance, audits during the study and/or after study completion. In addition, pre-audits will be performed for investigators who have received notification of an impending regulatory audit. Audits will include but are not limited to:
a. Study Documents:
Protocols and amendments, advertising material, IRB approvals and correspondence, curriculum vitas, FDA 1572 Form, current lab certificates and normal values, drug storage and accountability to include shipping, receipt, dispensing and return records, monitoring records, sponsor and investigator correspondence, investigator brochure, serious adverse events and safety updates.
Based upon CRFs, establish a database and data validation plan prior to study initiation. Clinical data will be double entered into the database. Data verification and database audits will be performed according to protocol specific data validation plans.
Statistical Analysis
Develop data analysis plan based on the protocol and perform statistical analysis using SAS application.
Statistics and Clinical Trial Report
According to the ICH GCP guidelines, draft the clinical and statistical report, and arrange meetings with the sponsor and investigators to finalize the report.
Clinical Trial Final Meeting
As per request by the sponsor or the principal investigator (PI), prepare materials for presentation of study results.
