BERG International Clinical Research

BERG International Clinical Research is a Mexican full service company within the Medical Clinical Research activities for the Pharmaceutical Industry. The company's profile allows to develop a wide range of services accordingly to our clients needs to be offered in Mexico as for the rest of Latin American countries within the classification of a Contract Research Organization.

The company headquarter offices are located in Mexico City where the knowledge of the clinical, regulatory and operational activities is very complete with strategic joint ventures made with local companies for the rest of Latin America

It is structured in following operational divisions:

• Clinical Research Operations
• Regulatory Affairs
• Education & Training
• Human Resources Outsourcing

BERG's main professional target is to develop serious and responsible Medical Clinical Research in strict compliance with international and local regulatory guidelines and Good Clinical Practices in order to offer competitive and reliable services at international and local services within Mexico and the rest of Latin America.

To represent confidence and efficiency in Clinical Trials conduction and Personnel Training services.

To obtain a complete confidence on BERG's professional honesty and engagement with the most important medical development area which is the Clinical Research considered by BERG as its primary objective to develop new pharmaceutical therapies at worldwide level.

Directive and Operational Staff is hired only according to proven previous experience in Clinical Research, proven background in personal skills to develop successful operative activities, after receiving a strict Training Program developed and registered by BERG as a contracting requirement, and fully bilingual evaluated by strict examinations to guarantee work quality

Clinical Operations Division

I.- ADMINISTRATIVE MANAGEMENT FOR MEDICAL CLINICAL TRIALS ADMINISTRATION AND START UP:

Identification and solution in advance to conduct the clinical trials in time and avoiding potential regulatory and operational problems according to the specific regulatory requirements in Mexico and Latin America which includes Clinical Trials Crisis Intervention. Administrative and Clinical staff is a very well trained personnel, fully bilingual with specific profiles according to the particular needs of our clients. BERG only operates under strict, consistent and valid Standard Operation Procedures at local and international level.

II.- CLINICAL MONITORING :

• Clinical Trials Phase I to IV. Design, Management, Conduction, and ancillary services local implementation if required.
• Bioequivalence studies
• Protocol Management: Activities development and continuous Quality Assurance activities on Informed Consent process, CRF and ancillary documents and services, review, translations, printing.
• Feasibility studies
• Sites & Investigators identification, pre-study site visits, Quality Assurance process for pre-selection and Assessment on Investigators qualification/selections/authorizations accordingly to local previous performance.
• Study Set-up activities: Study Master and Site Files implementation, tracking tools, manuals implementation, Fees negotiations/agreements with sites and Investigators accordingly to sponsors guidelines strictly.
• Regulatory Submissions to ECs/IRBs and MoH authorities. Documents package preparation, translations, submissions, tracking of submission timelines.
• Investigators/Team Meetings. Organization and planning, CRA protocol specific training, Investigators/Sites specific trainings according to sponsors guidelines and needs detected.
• Patient Recruitment, Project Management and Administration:
  • Project Management during the entire study period
  • Maintenance of databases
  • Study status reports
  • Continuous training and Quality Assurance activities to the study team assigned by the company and to the sites staff involved.
  • Management of budget, timelines and vendors
  • Financial Administration
• - Monitoring:
  • Quality Assurance/ Regulatory audits to start study Initiation Visits for every clinical trial
  • Monitoring & Co-Monitoring visits
  • Study specific Monitoring Plan and Report Development
  • Monitoring of enrollment rates and patient eligibility criteria
  • Regulatory adherence to specific local and international guidelines
  • CRFs review and design. Review of consistency of data, manual query generation and resolution
  • CRF delivery of queries cleaned/verified.
  • Study site internal audits
  • Study source data verification
  • Study specific documentation development and management
  • Development of SOPs for study site management activities and Quality Assurance activities to verify compliance
  • Study Close out visits
  • Follow up activities after Study Closure
• Medical Support, & Assessment.
• Medical support to study sites
• Medical check of study data
• Pharmacovigilance
  • Drug Safety
  • SAE reporting and related reporting activities
  • Quality Control and Assurance Quality control and audits

Regulatory Affairs Division

I. Implementation & follow-up of clinical trials regulatory supervision for full compliance locally or internationally

II. Quality Control to all regulatory affairs requirements either with local ECs/IRBs or MoH authorities. Assessment and submissions services in this area.

III. Development of specific SOPs for local processes and regulatory compliance to FDA, ICH and local regulations accordingly to our clients needs.

IV. Regulatory Consultancy Services for Mexico and Latin America.

QUALITY CONTROL DEPARTMENT WITHIN REGULATORY AFFAIRS DIVISION

I. Systems Implementation of QA processes and manuals accordingly to the sponsors needs.

II. Internal Audits Program and in Sites Study Conduction since the trials implementation and initiation phases to their closure as a continuous routine BERG´s procedure.

III. Conflicting matters identification and action plans to straight them up accordingly to each clinical trial.

IV. Independent Auditing Conduction services for clinical trials developed in Mexico by either pharmaceutical companies or CROs, followed by detailed and confidential Audit Reports to the sponsor company in a timely and professional manner.

Educational and Training Division

• Internal and External Continuous Training Programs for study staff involved within pharmaceutical companies and Site staffs related to GCPs, Bioethical matters, and Study Development validated by recognized academic institutions in Mexico and registered as BERG's property.
• External training solutions on specific clinical trials and personnel training needs to Pharmaceutical companies

Human Resources Outsourcing Division

I.- Contract Staff Services
II.- Qualified personnel identification according to specific profiles requested for study staff
III.- Staff selection assigned to each clinical trial under strict training requirements and performance quality confirmed previously.

Contact Information

BERG International Clinical Research

Av. Reforma No. 350 - 11th Floor
Col. Juárez, Mexico City 06600 México
Phone: (+52-55) 9171-2015
Fax: (+52-55) 9171-1499
E-mail:

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