CONTRACT RESEARCH ORGANISATIONS

Agile operational staff have a wealth of experience conducting clinical research trials globally and across the Asia-Pacific region. George Clinical’s management team is drawn from large pharmaceutical companies and global contract research organizations. The Agile Clinical team’s experience spans all major therapeutic areas and all phases of clinical research. 

We are engaging with scientific leaders from a broad range of therapeutic disciplines. George Clinical’s scientific leaders are highly respected leaders in their field and are regularly called upon by global policy makers in the formulation of best policy and the delivery of best practice. As such, Agile Clinical offers a clinical trial service of the highest scientific calibre.

Agile brings today a vast number of projects-experience in all Clinical trial phases and major therapeutic indications, including Oncology, Hematology, Cardiovascular, Orphan Diseases, CNS, First in Human, and Pivotal studies in Medical Devices, with senior project managers that bring an average of 10 years of experience gained in CROs and Pharmaceutical companies. We endeavour to satisfy our clients & partners requirements and expectations by working closely with them to facilitate the efficient management of their projects and the success is traduced to establish long strong relationships with our business partnerships.


Services

Documentation updates and maintenance

  • Project Tracking
  • Vendor Management
  • Logistic and Depot Management
  • Laboratory Management (sample storage)
  • Local and Central safety management
  • Communication with Investigator, Site, Sponsor and Vendor
  • Inspection Readiness and mitigation planning

Best strategies for approaching the Regulatory Agencies

  • Best strategies for approaching the Regulatory Agencies
  • Preparation and Submission of regulatory package to Ethic Comities and IRBs
  • Import / Export license application

The scopes of the legal representation is documented with a Power of Attorney which enabling Agile CRO to act as the sponsor for

  • Submission of regulatory package to Ministry of Health (MoH)
  • Submission of regulatory package to Ethic Comities and IRBs
  • Import of Records
  • Sign contracts with investigators and vendors

Investigator contract template development and negotiation

  • Investigator budget development and negotiation
  • Contract execution

Study plans and guidelines

  • Implement process tailored for a specific project
  • Patient recruitment strategies
  • Patient Retention policies
  • Identify training needs and train the team and sites
  • Identify vendors to collaborate with the study
  • Kick-off meeting
  • Investigator / CRA meeting

Best countries, Investigators and Sites for conducting a Clinical Trials

  • Strategies for developing the Project based on the incidence/prevalence of a disease, regulatory timelines, and recruitment profile
  • Enrolment Projections and anticipate possible issues
  • Overall Implementation costs
  • Review the competitive regional and global landscape

Investigator and site identification, selection, and qualification

  • Site Initiation, routine monitoring and close out visits
  • Site management
  • Site staff continuous training
  • Source data verification
  • Trial Master File maintenance and update

Conduct of quality GCP audits

  • Conduct of contract vendor/supplier audits
  • Conducts internal / external GCP training
  • Development of Quality Plans and Quality Manuals for a specific project
  • Auditors certified globally with experience in US, EU, APAC and LATAM

Medical Monitoring

  • Medical Liaison
  • Pharmacovigilance