5450 Chemin de la Côte-des-Neiges

Suite 522

Montréal, Qc

H3T 1Y6

514-282-4523

info@exactis.ca

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© 2018 by Exactis Innovation

Clinical Development Unit Capabilities:
  • Study development: Exactis can provide critical information and scientific perspectives during the development and implementation of your study by facilitating collaborations and consultations through our network of key opinion leaders, and statistical and regulatory experts. Our expertise, combined with access to key opinion leaders, will result in a focused, feasible and well-designed study that will be readily accepted by sites and regulatory agencies.

  • Medical writing: Medical writers at Exactis have extensive experience in all aspects of the regulatory writing process, including protocols and clinical study reports, as well as manuscripts for peer-reviewed journals. We implement a rigorous review process to ensure that ICH-GCP and applicable regulatory requirements are met.

  • Study start-up: Access to Exactis’ oncology network of investigators and sites will lead to faster site selection, feasibility and contract and budget negotiations. Our study start-up team will ensure that all pre-study activities are initiated promptly and efficiently including Investigator meeting and site initiation visit (SIV) planning and vendor selection.

  

  • Regulatory submissions: Our regulatory submission staff will provide the guidance, coordination and submission of clinical trial applications, amendments, and reporting of SAEs and will ensure that your study is compliant with regulatory requirements.

  • Project and site management: Our Project Managers work closely with the study team from start to finish to ensure every aspect of the study is planned for and properly executed. Our project management methodology incorporates standardized processes for reviewing study progression, risk management, assessment and mitigation. Study-specific tools are created to track and manage study metrics such as, enrolment status, essential documents, monitoring, participant and CRF tracking, drug accountability, data queries, and adverse events. Our goal is to complete every study on time and on budget while ensuring the highest quality.

  • Monitoring: We provide on-site and remote monitoring activities. Our monitoring is conducted in accordance with a well-designed monitoring plan, ICH-GCP guidelines, applicable regulatory requirements, and our SOPs. Our study monitoring services includeInitiation visits, on-site and remote study monitoring visits (remote and on-site) and close-out visits. 

  • Data management:Our clinical data management team can develop and/or manage all your data management based on sponsor’s needs including paper or electronic case report form (CRF) development, statistical analysis and data reporting. 

  • Drug safety and pharmacovigilance: The Exactis safety team will implement an effective safety management plan to collect, manage and report AEs/SAEs to sponsors, sites, and regulatory agencies. 

  • Investigator initiated trials: Exactis will provide personalized support for Investigator-Initiated Trials (IITs) to ensure a well-designed, ICH-GCP-compliant study and that all necessary clinical trial logistics are established. Exactis can assist in reviewing and optimizing the study concept and design, as well as developing a detailed study budget that can be used to secure funding.