LBBM CRO Contract Research Organization
LBBM Biomedical Research
History of LBBM Research Clinical Trials
Staff of LBBM Bioequivalence
LBBM Quality Assurance
LBBM Contact CRO
Clinical Trial Research in Argentina
Pharmacokinetic Studies
Biomedical research Clinical Trial protocol writing Clinical Trials CRO Site Selection Drug distribution in Clinical Trials Biotechonolgy LBBM Bioanalisis Auditing Consultancy Clinical Research Trials
 
<h1>CRO Contract Research Organization</h1> <h2>CRO Clinical Trials</h2> <ul> <li>clinical research coordinator</li> <li>cro business</li> <li>cro clinical</li> <li>cro clinical research</li> <li>cro clinical trial</li> <li>cro companies</li> <li>cro company</li> <li>cro contract</li> <li>cro directory</li> <li>cro guide</li> <li>cro media de</li> <li>chiltern cro</li> <li>cro online</li> <li>cro pharma</li> <li>cro research</li> <li>cro services</li> <li>international cro</li> <li>pharmaceutical cro</li> <li>preclinical cro</li> <li>quintiles cro</li> <li>site cro</li> <li>cro</li> <li>cros</li> <li>cro africa</li> <li>cro argentina</li> <li>cro brazil</li> <li>cro canada</li> <li>cro china</li> <li>cro europe</li> <li>cro india</li> <li>cro japan</li> <li>cro latin america</li> <li>cro latinamerica</li> <li>cro mexico</li> <li>cro south america</li> <li>cro southamerica</li> <li>cro us</li> <li>cro usa</li> <li>phase 1 - phase I</li> <li>phase 2 - phase II</li> <li>phase 3 - phase III</li> <li>phase 4 - phase IV</li> </ul>

CLINICAL TRIAL ORGANIZATION

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  • Design and Writing of the protocol
  • Design and Writing of the CRF and Informed Consent
  • Regulatory Submission
  • Follow up of the approval process
  • Import procedures and customs
  • Project management and monitoring
  • Data management

Design and Writing of the protocol: We write the protocol in Spanish and/or English according to all the national and international guidelines and regulations. We do the sample size calculation, protocol design and writing. We also review the protocol design with opinion leaders in the specific area of interest.

Design and Writing of the CRF and Informed Consent: according to the specific requirements of the sponsor, ethics committees, and the Ministry of Human Rights, we write the Patient Information Brochure /ICF with all the highlights which will assure a fast approval and a comprehensive language for our population.

Regulatory submissions: we manage a profound knowledge of working procedures and approval timelines of the committees of several institutions and the Ministry of Health (ANMAT) in Argentina and also in limiting countries. Having a close communication with institutions and investigators and specific requirements of each site, we obtain fast approvals.
We also meet with the MoH evaluators previous to the submission of the study in order to foresee any objection on study rationale, design or feasibility and accordingly suggest modifications to the protocol, optimizing the submission strategy.

Follow up of the approval process: Once submitted, we regularly hold telephone communications and meetings with the in order to have a close follow up of the evaluation process. Especially in phase I trials, when the pharmacology Unit of the MoH that evaluates preclinical information is involved, we know where the study stands and try to anticipate as much additional information as possible. This avoids unnecessary delays in the approval.

Import procedures and customs: We work with specialized customs brokers in order to speed up the import process for study medication. LBBM import experience is wide on clinical studies medication and also on alternative study products, such as nutritional supplements, in which case other governmental departments have to take intervention in the approval of the import license.

Project Management: we do exhaustive project management, since the planning of the study until the resolution of the last query: Initiation visits, monitoring, close out visits, periodic reports, SAE reporting, Site Specific Files management, etc

Data Management: together with our statisticians we offer the study design and calculation of sample size, interim analysis, and final statistic analysis. We also have experience in eCRF management and work close together with the sites with variable experience with this tool in order to improve the use of it, which results in the most updated database available to the sponsor.

 

llbmClose communication with the sponsor and the investigators,, serious scientific feedback on study design and rationale, careful selection of the sites, strategic submissions, close follow up of the approval process: our keys to fasten the start up phase and to accomplish a comprehensive project management that will lead to the success of your trial. lbbm