Clinical Research Solutions

Consulting

Clinical development planning.

Guidance on local regulations.

Supervision of local and regional studies.

Application of quality standards.

Outsourcing

Coverage of short-, medium-, and long-term staffing needs.

Medical Committees

Selection and integration of participants

Operations manual and internal regulations

Registration with CONBIOÉTICA and COFEPRIS

Clinical Management

Project management.

Selection and training of study sites.

Drafting and review of proposals for clinical trials and epidemiological studies.

Recruitment and follow-up of participants.

Clinical monitoring.

Data collection, management, and analysis.

Final study reports.

Application of quality standards and external monitoring.

Pharmacokinetics.

Compilation and review of regulatory files.

Health Procedures

Sanitary licenses for hospitals, clinics, pharmacies, and laboratories

Notification of Health Officer

Operating notices (offices, opticians, pharmacies, spas, etc.)

Renewals and cancellations of licenses and notices

Record modifications: change of address, business type, health officer

Health registrations for medicines, medical devices, and hospital equipment

We manage your regulatory compliance with COFEPRIS

Specialized Services

Protocol planning and design

Operational implementation of the study

Regulatory approvals and ethics committees

Monitoring, Control, and Follow-up of the Trial

Clinical Monitoring

CRA, regulatory audits

Initiation visits and remote monitoring

Consulting for Sponsors

Design of regulatory strategies

Roadmap for study approval and execution

Our Services

At Kali Clinical Research, we offer comprehensive solutions for the development of clinical trials and epidemiological studies, ensuring compliance with the highest standards of quality, efficiency, and ethics.

Comprehensive Clinical Trial Management

From planning to execution, we manage trials in all phases (I, II, III, and IV), ensuring scientific accuracy and regulatory compliance in every study.

Fast and Efficient Patient Recruitment

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Protocol Development and Evaluation

We design customized strategies for each study, ensuring effective methodologies aligned with international regulations.

Regulatory Compliance and Good Clinical Practices (GCP)

We adhere to strict safety, ethics, and quality protocols, ensuring compliance with national and international regulations.

Study Monitoring and Follow-up

We oversee every stage of the clinical trial to ensure proper execution, minimize risks, and optimize results.

Management of Medical Devices and Investigational Drugs

We coordinate the logistics and management of investigational products, ensuring safety and traceability in every trial.

Kali Clinical Services

  • Our services cover the full cycle of a clinical study: from initial planning to the delivery of final results ready for regulatory submission.
  • Clinical Research
  • Design and planning of clinical trials Phase I–IV
  • Protocols, amendments, and operating manuals
  • Feasibility assessment and site selection
  • Study management and monitoring
  • Clinical coordination and patient management
  • Quality control and internal audits
  • Regulatory Support
  • Preparation and review of files for COFEPRIS, FDA, and international agencies
  • Assistance during inspection visits
  • Ethical management with Research and Ethics Committees
  • Oversight of compliance with ICH-GCP and national regulations
  • Data Management and Statistics
  • Development of electronic CRFs
  • Data management and validation
  • Statistical analysis and final reports
  • Preparation of manuscripts and scientific publications
  • Pharmacovigilance
  • Real-time safety monitoring
  • Adverse event reporting
  • Systems and processes aligned with international standards
  • Training and Certification
  • Courses for investigators, coordinators, and clinical sites
  • Continuous training in ICH-GCP, Mexican regulations, FDA, and E6(R3)
  • Internal and external certification for research teams

Regulatory Compliance
Each study is conducted according to the following guidelines:

  • ICH-GCP E6(R2)/E6(R3)
  • Mexican Official Standard NOM-012-SSA3
  • COFEPRIS Guidelines
  • FDA and EMA requirements, as applicable

Who Do We Work With? We collaborate with:

  • Pharmaceutical laboratories
  • Medical device companies
  • Biotechnological companies
  • Academic institutions
  • Hospitals and medical offices
  • Independent principal investigators
  • For both local and national or international multicenter studies.

Why Choose Kali Clinical Research?

At Kali Clinical Research, we stand out for our expertise, precision, and commitment to clinical research. We work alongside pharmaceutical companies, healthcare institutions, and medical device developers to ensure the success of every study.

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Who We Are?

At Kali Clinical Research, we are a clinical research organization (CRO) dedicated to conducting high-quality clinical trials and epidemiological studies. Since our founding in 2015, we have collaborated with the pharmaceutical industry and healthcare institutions to drive medical innovation, ensuring regulatory compliance, participant safety, and accuracy of results.