Newsletter
Magazine Store

June 2024 Edition

An expert offering full service in the field of Clinical research, bringing solutions to the CRO, Pharmaceutical, Biotech and Medical Device Industry: ACTIVA CRO

thesiliconreview-gabriel-desanto-partner-activa-cro-24.jpg

ACTIVA CRO is a distinguished full-service Contract Research Organization (CRO) with a prominent presence across Latin America. Since its inception in 2003, the company has dedicated itself to supporting the CRO, Biotech, Pharmaceutical, and Medical Device industries by offering a comprehensive suite of services tailored to the clinical development of healthcare products and solutions. Headquartered in Buenos Aires, Argentina, ACTIVA CRO has rapidly expanded its reach, establishing significant operations in Argentina, Chile, Uruguay, Brazil, Peru, Mexico, and Colombia, thereby solidifying its reputation as a key player in the “southern cone” of the continent. By 2008, ACTIVA CRO had evolved into a regional powerhouse, further extending its network to include Panama, Costa Rica, and Ecuador. This strategic expansion allowed the company to transform into a truly integrated regional CRO, capable of delivering seamless and high-quality clinical research services across multiple Latin American countries. This growth has enabled ACTIVA CRO to manage a vast array of projects, encompassing all phases of clinical trials and covering major therapeutic areas such as Oncology, Hematology, Cardiovascular diseases, Orphan Diseases, Central Nervous System (CNS) disorders, First-in-Human studies, and pivotal trials in medical devices.

One of ACTIVA CRO's core strengths lies in its experienced and proficient project management team. With senior project managers averaging over a decade of experience in both CROs and pharmaceutical companies, the organization ensures that each project benefits from seasoned expertise and meticulous oversight. This depth of experience has been pivotal in successfully navigating the complexities of clinical research and achieving favorable outcomes across diverse therapeutic domains. ACTIVA CRO prides itself on being an expert in the Pharma, Biotech, and Medical Device sectors, offering highly personalized and top-quality clinical research services. The company’s ethos revolves around closely collaborating with clients and partners to meet their specific requirements and expectations. This client-centric approach has fostered long-lasting and robust business relationships, underscoring ACTIVA CRO’s commitment to delivering excellence in clinical trial management. A cornerstone of ACTIVA CRO’s operational philosophy is its stringent control and surveillance of clinical research trial processes. The management team, enriched with extensive experience from both global pharmaceutical and CRO environments, is dedicated to maintaining the highest standards of quality in clinical research. This dedication is manifested through the development and implementation of a robust Quality Management System (QMS) inspired by global standards, ensuring that every project adheres to stringent regulatory and ethical guidelines.

ACTIVA CRO's board of directors is resolute in their commitment to enhancing the quality and reliability of clinical research in Latin America. By continuously developing and refining their services, they aim to position Latin America as a preferred destination for clinical trials. The company’s mission is to provide high-quality deliverables that meet the exacting standards of their global clients, thereby contributing to the advancement of healthcare through innovative and effective clinical research. ACTIVA CRO stands out as a leading Contract Research Organization in Latin America, known for its extensive project experience, expert management, and unwavering commitment to quality. Through strategic expansion and a client-focused approach, ACTIVA CRO continues to play a pivotal role in the clinical development landscape, driving forward the progress of healthcare products and solutions in the region.

Clinical Research And Trials Services

ACTIVA CRO offers an extensive array of services tailored to meet the needs of the Pharmaceutical, Drug, Biological, and Device industries, providing comprehensive outsourcing solutions in the field of clinical research and trials. With a commitment to quality and efficiency, ACTIVA CRO ensures that every aspect of clinical research is meticulously managed, from initial project feasibility through to final reporting and regulatory compliance.

Clinical Research and Trials Services

Clinical Project Oversight ACTIVA CRO delivers full-spectrum oversight for clinical projects, ensuring that all activities are seamlessly coordinated and aligned with project goals. The Clinical Project Manager (CPM) plays a pivotal role as the primary liaison between the sponsors and ACTIVA CRO. The CPM's responsibilities include:

  • Documentation Updates and Maintenance: Ensuring that all project documentation is current and meticulously maintained.
  • Project Tracking: Monitoring project progress and ensuring timelines are adhered to.
  • Vendor Management: Coordinating with various vendors to ensure they meet project requirements.
  • Logistic and Depot Management: Handling the logistics of project materials and managing storage facilities.
  • Laboratory Management: Overseeing the management of laboratory samples and ensuring proper storage protocols.
  • Local and Central Safety Management: Ensuring that safety management protocols are followed both locally and centrally.
  • Communication: Facilitating effective communication between investigators, sites, sponsors, and vendors.
  • Inspection Readiness and Mitigation Planning: Preparing for inspections and developing strategies to mitigate potential issues.

Inspection Readiness ACTIVA CRO prioritizes inspection readiness, ensuring that all clinical trials are prepared for regulatory inspections at any stage. This involves rigorous planning and continuous monitoring to identify and address potential compliance issues proactively.

Regulatory Affairs ACTIVA CRO provides expert regulatory affairs services, navigating the complex regulatory landscape to ensure that all clinical trials comply with local and international regulations. This includes preparing and submitting regulatory documents and liaising with regulatory authorities.

Legal Sponsor Representation ACTIVA CRO offers legal sponsor representation, ensuring that all legal aspects of clinical trials are managed efficiently. This includes contract negotiations and execution, ensuring that all agreements are in place and compliant with relevant regulations.

Investigator Contract Negotiation

ACTIVA CRO excels in contract management with investigators and sites, leveraging extensive legal expertise to streamline the process and save regulatory time. Services include:

  • Investigator Contract Template Development and Negotiation: Creating and negotiating templates tailored to specific project needs.
  • Investigator Budget Development and Negotiation: Developing and negotiating budgets that aligns with project requirements.
  • Contract Execution: Ensuring that all contracts are executed promptly and accurately. 

Quality Assurance

ACTIVA CRO’s commitment to quality assurance is evident in its rigorous processes designed to ensure the highest standards in clinical research. This includes continuous monitoring and evaluation of project activities to ensure compliance with industry standards and regulatory requirements.

Medical Affairs

ACTIVA CRO provides comprehensive medical affairs support, offering expert guidance and oversight to ensure the scientific integrity of clinical trials. This includes protocol development, medical monitoring, and consultation services.

Clinical Staffing Solutions

ACTIVA CRO offers specialized staffing solutions, providing highly trained clinical staff to support various aspects of clinical trials. This ensures that projects are staffed with experienced professionals who can deliver high-quality results.

Project Start-Up and Feasibility

ACTIVA CRO conducts thorough project feasibility analyses, collaborating with sponsors to generate study plans and guidelines tailored to specific project needs. This includes:

  • Patient Recruitment Strategies: Developing effective strategies to recruit the required patient population.
  • Patient Retention Policies: Implementing policies to ensure high levels of patient retention throughout the study.
  • Training Needs Identification and Execution: Identifying training requirements and providing necessary training to the team and sites.
  • Vendor Identification and Collaboration: Identifying and coordinating with vendors to support the study.
  • Kick-Off Meetings and Investigator/CRA Meetings: Organizing and facilitating meetings to ensure all stakeholders are aligned and informed.

Project Monitoring

ACTIVA CRO provides comprehensive project monitoring services, ensuring that all aspects of the clinical trial are conducted in accordance with the study plan and regulatory requirements. This includes continuous oversight and timely reporting to sponsors.

ACTIVA CRO offers a robust portfolio of services designed to support the entire lifecycle of clinical research and trials. Their expertise, coupled with a client-centric approach, ensures that sponsors receive high-quality, efficient, and compliant services tailored to their specific needs.

Gabriel Desanto, Director & Partner

“ACTIVA CRO has vast experience in contract management with investigators and sites gained by years, our legal knowhow speed the process saving regulatory time.”

NOMINATE YOUR COMPANY NOW AND GET 10% OFF