Located in Buenos Aires, Mautalen is one of the most important sites running Clinical Trials in Latin America. We have participated for more than 20 years in clinical trials related to several therapeutic areas.
BAKGROUND IN CLINICAL TRIALS
The company has provided services for the Global Pharmaceutical Industry since 1996 by means of managing patients on clinical trials on behalf of pharmaceutical Companies and Contract Research Organization. Mautalen employs highly qualified staff members including Sub Investigators, Study Coordinators, data entry, administrative employees and laboratory, DEXA, X-ray, spirometry and ECG technicians. Our experienced and well-qualified staff ensures that Studies are completed complying with ICH/GCP standards according to the exact specifications and protocol designs.
* Metabolic Bone disease
* Respiratory Diseases
* Women Health
FACILITIES AND EQUIPMENT
The Clinical Research Division facilities includes:
Laboratory includes extraction boxes, handling and shipping of samples’ area, short-term storage facility for lab supplies and the following equipment:
• Freezer (-20)
• Elcsys 1010 Analyzer
• ELISA technology
• Ion-Exchange Electrodes
Bone densitometry, Radiology, Respiratory and ECG Units include the following equipment:
• Hologic Discovery W
• Lunar Prodigy
• 12 Leads ECG
● MEDICAL AREA
We have medical offices, all of them with calibrated weight scale and stadiometer. Our comfortable waiting rooms with free refreshments offer a welcoming environment to our patients.
● OPERATIONS AREA
All our administrative and operation premises are fully equipped with high-speed Internet access, photocopy machine, computers and fax; they also have a special area for the storage of documents. Our facilities include a specific storage area for both, dry and refrigerated drugs with secure temperature control and an emergency power supply set to guarantee stable temperature.
We have specific boxes with high-speed Internet access specially designed to support CRA activities in our site.
Feasibility assessment is answered within 72 working hours. Each requirement is carefully evaluated by a multidisciplinary team, which includes medical and operations expertise.
If you wish to send Feasibility Questionnaires, please do not hesitate to contact any of the following:
0054 114514 3410
Clinical Operations Manager
0054 114514 3406
At Mautalen we achieve fast and efficient recruitment mainly through our 25.000 patient database, forthcoming patients and referrals. We consistently achieve and improve the recruitment projections committed during the feasibility process.
We place special attention in selecting suitable patients to achieve the lowest possible screening failure ratio for our clients.
We have recruited more than 5000 patients for different Studies in the last years.
CLINICAL OPERATIONS MANAGEMENT
Through our Clinical Operations Management, in charge of Quality Assurance, we guarantee that all clinical trial activities comply with GCP standards, local regulations, ethic requirements and protocol designs. Among its main responsibilities, it is in charge of preparing the site for audits and inspections, and of overseeing the submission of documents to the Ethics Committee and to the Regulatory Agencies. It is also responsible for the supervising the training operations.
By means of this program we have successfully gone through FDA Audit and EMEA audits with no actions indicated and through several Quality Assurance Audits from different clients as well.
Our operations staff performance is measured by several Key Performance Indicators (KPI). KPI have demonstrated to be a valuable tool to induce staff behavior in achieving high standard quality results.
We are committed to achieve the highest level of patient care and patient safety. All the staff is trained to give a kind, comprehensive and professional care to meet high standards in patient retention. At this moment, we have an average of 88.6% of patient adherence at the end of the first year or end of the trial. This shows an excellent compliance ratio with treatments.
● DATA QUALITY
We are committed as well to deliver clean and consistent on Schedule data, using Electronic CRF.
It is not easy to obtain and interpret quantitative measures of data quality due to the variety of CRFs and monitoring methods in use. However we have found that a good indicator is the data query rate. Basing on the KPI of the data entry staff, we can state that we have an average ratio of 4 queries per patient, which are solved within 4 days. We achieve this level of quality by providing ongoing training to the staff members, by the client´s feedback, and by auditing our own procedures
Staff Performance impacts on our client´s satisfaction and data delivery. All new staff is given a comprehensive induction. Their needs on individual training are assessed and the required training is provided on an ongoing basis.
- Good Clinical Practicesv - Local regulations
- Specific procedures to conduct clinical trials: CRF completion, source data completion, CRF query resolutions, drug accountability records and site files
- Site initiations, attended by each trial staff
- SOP training (Standard Operating Procedures)
- Therapeutic areas training – dedicated to specific Studies
- IATA training for lab technicians
● INDEPENDENT ETHIC COMMITTEE (IEC)
The IEC was established by Mautalen Research in 1996 to comply with ethical requirements in conducting trials. Its mission statement is to safeguard the rights, safety and well-being of all subjects enrolled in trials conducted at our site, according to GCP standards.
The IEC is constituted by seven members who have the qualifications and experience to evaluate the scientific, medical and ethic aspects of trials. Copies of its written procedures and membership lists are available for investigators, sponsors and regulatory authorities. Meeting are scheduled twice a month and its commitment is to review documentation in a timely manner.