CLINQUA provides clinical research services for pharmaceutical and biotechnology product development from phase II through phase IV for US, Canadian and multinational pharmaceutical companies. ClinQua is your way to high quality design, conduct and analysis of clinical trial.

As a Contract Research Organization our goal is 100% Customer satisfaction. Quality and value for money is always equally high across all areas in services provided by us.

We Focus Only on What We Can Do Well:

• We are the best in selected areas.
• We turn away work that we cannot do better than others.

• Cardiovascular
• Respiratory
• Oncology
• Hematology
• Transplantlogy
• Immunology
• Dermatology
• Ophthalmology
• Endocrinology
• Pain Management
• Anesthesiology
• Neurology
• Spinal Cord Trauma
• Dialysis
• and some other areas

Monitoring:

• Medical Monitoring (including 24/7 Medical Monitor coverage)
• To enhance regulatory compliance, our Medical Monitor is assigned to every project and is accessible 24 hours a day, every day to handle critical situations.
• Clarifying inclusion/exclusion criteria with the investigator.
• Providing consultation for potential safety issues or medical concerns regarding the clinical study.

Clinical Monitoring

• ClinQua CRAs perform comprehensive site management and monitoring activities to include the following types of monitoring visits:
  • Pre study qualification visits
  • Initiation visits
  • Interim monitoring visits
  • Close out visits

All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.

The paramount responsibility of CLINQUA CRAs is to ensure patient rights, safety and data integrity. This is accomplished through ongoing review of the following:

• Informed consent process
• IRB/IEC approval
• Ensuring proper AE and SAE reporting and
• documented follow up
• Adherence to the protocol
• 100% source documentation verification and data query clarification
• Investigational product administration and accountability
• Protocol Compliance
• Site training and support

CLINQUA CRAs ensure ongoing site compliance via the continual ongoing review of the following:

• Site staff qualifications and experience
• Site staffing, facilities, storage and equipment
• Accessibility and eligibility of subjects
• Review and retrieval of regulatory documents
• Accurate and timely completion of all CRF and
• source data

In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused.

These activities include the following:

• Site Visit Report and follow-up letters
• Review of safety reports
• Providing site training and support through communications
• Generation of status reports
• Maintenance of tracking tools/logs
• Facilitation of DCF resolution

CLINQUA CRAs complete comprehensive site visit reports and follow-up letters which are provided to the CLINQUA project management team within 10 working days of the visit; however, all urgent issues are immediately reported to project management. The visit reports provided by the CRAs include detailed action plans for all issues identified and all issues are tracked through to resolution.

In summary the CLINQUA CRA plays a major role in the successful conduct of a study. The relationship developed between the CRA and the site staff is such that there is a focus on open effective communication with the CRA providing training and support thus ensuring patient safety, data quality and maximizing patient enrolment.

Site Qualification (Pre-Study Visits)

CLINQUA's site management and monitoring procedures will be performed in accordance with ICH-GCP to ensure each investigative site%92s compliance with regulations and protocol requirements, and to enhance expeditious enrollment of appropriate patients into the clinical study. Regulatory documents will be reviewed by the CRA on an ongoing basis during the study conduct phase, including verification of signed informed consent forms and investigator IRB notifications.

The CLINQUA CRA will review the following information at the pre-study site visit:

• Latest version of the Protocol for this study
• Consent form process
• AE and SAE reporting procedures and contact information
• Case report form completion and maintenance
• Source documentation requirements
• Drug accountability requirements

In addition, to ascertain that an identified investigational site is qualified to perform this study to CLINQUA's expectations, the CRA will review the following issues at the study site and report this "study profile" in a site visit report to CLINQUA and Sponsor:

• Principal investigator qualifications and experience
• Site staffing, facilities, storage and equipment
• Adequacy of and accessibility to subject population
• Access to source documentation
• IRB and ethics committee issues
• Laboratory and pharmacy certifications and normal ranges (if applicable)
• Investigator agreement and indemnification issues
• Recommendations for investigational site approval or exclusion from the study

Sites that have recently had a pre-study site visit performed by Sponsor or have worked with CLINQUA in the preceding six months may be exempt from a pre-study site visit. SPONSOR will provide CLINQUA with a list of any exempt investigators for this study.

Site Initiation

Once all regulatory documents and approvals are received, a site initiation visit will be scheduled for those investigators who are unable to attend the investigators' meeting. During this visit, the CRA will review the following with the principal investigator and his/her staff as appropriate:

• Study goals and obligations
• Investigator brochure
• Protocol procedures (with particular attention to inclusion/exclusion criteria, enrollment goals, adverse events, primary efficacy variables and GCP compliance)
• Informed consent procedure
• Randomization procedure
• AE/SAE reporting
• CRF completion and error correction/need for adequate source documentation
• Maintenance of the investigator binder and site visit log
• Laboratory sample handling procedures and results reporting procedures
• Clinical supply dispensation, accountability and storage procedures
• Any other issue as deemed important to the conduct of the study

Site Interims

The following issues are addressed at each interim visit as appropriate:

• Informed consent
• Source document verification 100%
• CRF completion (may be done remotely)
• Expedient data retrieval and query resolution
• Drug accountability
• Check and review of the regulatory binder and its contents
• Clinical supply inventory
• SAE reporting
• Enrolment issues and targets
• Protocol amendments
• Significant protocol deviations
• Acceptability of facilities
• Personnel changes
• Updated regulatory documentation
• Laboratory sample handling
• Any other issue as deemed important to the conduct of the study

Following each monitoring visit, CLINQUA will complete follow-up letters and site visit reports within 10 working days of the site visit date These follow-up letters and monitoring reports will be forwarded to Sponsor on a monthly basis.

Preparation and submission of report on Serious Adverse Events

Reporting serious adverse effects to the sponsor and to the FDA, according to SOPs and FDA requirements

Preparation patient case narratives and SAE case narratives

Writing narrative descriptions of both significant and serious adverse effects for inclusion in the Final Study Reports

Protocol review/input

Conduct literature searches as required Liaise with project managers, Study Physicians and Investigators to ensure best study design Co-ordinate with data management to ensure compliance with internal systems Ensure protocol undergoes internal review as per your company procedures

Informed Consent Form design

Assessing the completeness of Consent Form (review the Consent Checklist) Assistance with the development of a project-specific consent form

Study Manual development

Study Manual Preparation procedures to enhance performance quality and consistency Altering study methodology as required

Clinical trial registration/licensing

Our experience encompasses obtaining clinical trial approvals and registration of new chemical and biological entities, as well as established active ingredients. We can also provide assistance with post-registration activities, such as variations and renewals.

Regulatory submissions

We have experienced people to manage your submissions in compliance with all local regulations, for example registration of a new product.

Safety reporting

Patient safety and regulatory compliance are our primary concerns when conducting clinical studies. We work closely with our client's own drug safety department to provide safety surveillance and prompt, accurate reporting of serious adverse events.

Project management

Our project managers work in close cooperation with the scientific team to keep you formed on the progress of your clinical trial. As your representative, they are wholly attuned to your needs. They efficiently and diligently manage all critical aspects of the study to ensure on-time delivery of results

Our seasoned project managers make your project run smoothly, on time and on budget with a quality output. The project managers are responsible for:

• Main Sponsor Contact: our project managers serve as the main contact for our sponsors. They provide frequent and timely reports to our sponsors.
• Training: they organize the training of CRAs and site personnel on the protocol, CRF conventions and SOPs.
• Manage the Monitoring Effort: they organize and track monitoring coverage. Our managers supervise the CRAs on the project by reviewing their work, maintaining continuous contact, and conducting frequent conference call meetings to assure standards and consistency.
• Quality Control: our project managers review and approve reports and letters from the CRAs and periodically co-monitor and audit problem sites.
• Decision Making: they are capable of answering agreed-upon questions from the field regarding patient eligibility and study conduct.
• Proactive Approach: our project managers are one step ahead of the game. They anticipate problems and have solutions ready should they occur.
• Management of Budgets and Timelines: our project managers are fully responsible for keeping the project within budget and executing within the client's required timelines.
• General clinical trial support
• Identification of Phase I Units
• Local/Country Specific Lab Identification
• Study Supply Management
• Scientific clinical trial support
• Medical-scientific assessment of commercial, potential of new products
• Medical-scientific aspects of commercial product development
• Organization of round-tables, seminars, workshops, etc.
• Conferences, oral presentation and papers, etc.
• Training and teaching

Investigative sites audit

Verify that the protocol is performed according to Good Clinical Practices (GCP) and International Commission on Harmonization (ICH) standards and the sponsor's or CRO's Standard Operating Procedures (SOPs).

Review the informed consent content and process.

Review records and procedures concerning interactions with the IRB.

Review records and procedures concerning drug accountability.

Inspect study-required facilities and equipment.

Verify that the data collected in a representative sample of Case Report Forms (CRFs) are supported by source documents.

Assess compliance with internal SOPs.

Study documentation audit

Verify that the protocol is performed according to GCP and ICH standards.

Review records and procedures for site visits.

Review study file documentation.

Ensure internal systems used in the conduct of clinical trials are correct, including SOPs for Adverse Experience (AE) reporting, supplies distribution, and data handling.

Assess compliance with internal SOPs.

Compare study report versus the protocol, CRFs, and database.

Ensure internal consistency in reports.

Preparation for regulatory inspection

Covering:

• Trial master file audits
• System audits
• Site audits
• Central laboratory audits
• Data base audits
• Final clinical report audits

CRF design and review/input:

• Full collaboration with project and data management teams during design process
• Electronic distribution of draft documents for client review
• Prompt delivery of time critical documents
• Your Case Report Form can be designed at any stage between draft protocol and final protocol.
• We can use your standard templates or modules so that the CRF remains in your desired format and appearance.
• All forms are designed with the entire project team in mind to provide a CRF that is easy to complete and that will collect data of the highest integrity.
• Association with reputable & reliable print firms for production of NCR and bound documents.
• Development of CRF Completion Instructions/Guidelines
• Write CRF completion instructions for study sites to ensure the quality and integrity of collected data
• Provide input to CRF completion instructions
• Development of Validation Specifications and checks
• Programming of edit checks
• Provide input to Validations checks
• Development of query resolution conventions (Data Change Convention)
• Medical review of data
• Evaluating medical and scientific consistency of data
• Data cleanup activities include manual review of the CRFs and computer listings of data
• Review of marginal notes on CRFs and Data Alerts
• Medical review of data coding
• Review of coding of adverse events (MedDRA, WHO-ART, COSTART)
• Review of coding of concomitant drugs (WHO-DRUG)
• Consistency review of medical coding
• Serious Adverse Event reconciliation
• Reconciliation of safety database vs. study database

Contact Information

ClinQua Clinical Trials Inc.
Bruce Kriger, Director of Clinical Affairs, President
4370 La Jolla Village Drive
San Diego, CA 92122-1249 USA
Phone: 858-225-3997
Fax: 858-225-3997
E-mail:

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