Clinical Development

Building your project from an early phase planning and regulatory strategy to Clinical Operations to achive success.

Global Project management 

From PoC to post-marketing studies (Phase I, Phase II, Phase III and Phase IV).

Ensure trials are performed On time, On schedule and On budget.

Act as a liaison between Clients and Vendors and report the study progress periodically. 

Assess the compliance with GCPs/ ICH E6 (R2) and country applicable Clinical Trials regulation.

• Creating and implementing the Project Management Plan.

• Coordination of internal and external meetings. Communication Plan.

• Resources allocation, training and supervision.

• Managing issues and risks.

• Managing budget issues and invoices.

• Participating in Audits.

Start Up tasks and Regulatory Submissions According country applicable law

• Collaboration in the selection of participating sites. Feasibility questionnaire and PSSV/SQV

• Clinical Trial essential documents review, preparation and development. 

• Regulatory support for both Initial Submission and new amendments

• Regulatory Authorities Follow-up during the Clinical Trial development

• Registration of the Trial in public Database

• Site’s activation

Clinical Monitoring 

All monitoring tasks will be performed according to the Monitoring plan developed for the study and according to our Standard Operating Procedures (SOPs) and client needs. 

Modalities:

On-site monitoring

Risk Based monitoring (off-site data review)

Remote monitoring

• Site Initiation Visit, Site Monitoring Visits, Site Close-out visit

• Investigator Site File for participating sites

• Preparation of Audits and Inspections

Quality and Compliance 

Ensuring clinical trials and projects are designed, developed, and reported in compliance with all Regulatory requirements and Standard Operating Procedures (SOPs). 

• Risk based internal evaluation

• Preparation of Audits 

• Implementation of Corrective Action-Preventive Action (CAPA) process

Drug Safety and Pharmacovigilance 

Safety overseen during the trial development.

• Safety reporting to regulatory authorities (IRBs/ECs)

• Safety data analysis and reports such as DSURs and other periodic safety reports according to country regulations

Data management and Biostatistics 

Implementing adequate tools to analyze and present the data in appropiate formats

• eCRF design based on the variables for the trial

• Data management Plan

• Data Based lock and analysis of results

Medical Writing 

Providing the documents needed to support your research

• Essential documents for the trial (Protocol, HIP-CI, IB, …)

• Final Clinical Trial report

• Manuscripts