Clinical Trial Consulting

Expertise In
All Aspects of Clinical Development

Leveraging 20+ years of expertise in clinical research across Europe, North America, Latin America, Africa, and Asia-Pacific, we provide comprehensive services across all clinical development phases (Phase 1 to 3 and post-market) for sponsors and CROs, with respect to budget and not compromising with the highest standards of quality and patient safety.

Our aim is to help you navigate the complexities of clinical research with confidence and to provide you with solutions tailored to your needs, whether you are a big or medium-size pharmaceutical company, a biotech or Startup company.

For some projects, you may be short-staffed and may need the assistance of qualified consultant with professional experience who can step in and take in charge your clinical study activities. If this is the case, partner with us to drive excellence in a variety of clinical trial operations activities, including:

Study feasibility & Start-up

Need an experienced Clinical Trial Feasibility Specialist, Start-up Expert or Site Activation Manager?

We provide expert oversight and coordination of feasibility assessments to help optimize country & site selection and improve study success rates.

Feasibility Strategy & Planning

• Clinical study feasibility assessment
• Create study-specific documents (feasibility questionnaires, cover letters, etc.)
• Optimal country & site mix
• Recruitment projections
• Risks and opportunities
• Strategy, incl. timelines, milestones, and resource allocation
• Trial planning
• Study design feedback
• Protocol development

Study Start-up Sites Selection & Activation

Our expert provide support and leadership in all aspects of study start-up and site activation for your clinical trial, inclusive of timelines and regulatory strategy.

• Targeted Site & Investigator Identification, qualification and selection (incl. KOLs)
• Create study-specific documents (study operational plans, monitoring procedures, etc.)
• Resources allocation
• CRO/Vendor selection (including, RFP development, Specifications and Budget Analysis, Bid defense, etc.)
• CRO/Vendor oversight
• Timelines and Budget set-up & management
• Risks mitigation strategies
• Contracts negotiation and management (Suppliers and Sites agreements)
• Budget set-up and management

Global and Local Regulatory Support

Need an experienced Regulatory Specialist or Submission Manager?

We have significant clinical trial submission experience across a wide range of clinical trial programs including drugs, medical devices, vaccines, drug-device combination products, licensed substances which help prevent potential study approval and study initiations delays. We will guide you through the evolving EU regulations and provide you with all the options to help you choose the best strategy for you trial.

• Advice on national legislations and specific requirements
• Strategic submission planning expertise
• Regulatory package preparation : Adaptation of trial documentation to local requirements (e.g. Synopsis, Patient Information Notice and Informed Consent Form, Patient’s recruitment material, Application Forms, labels, insurance, import and export processes), translation management…
• Clinical Trial Applications dossier compilation and submission to local / European Health authorities and Ethics Committees (CTIS Part I, CTIS Part II)
• GDPR Compliance and Data Privacy Assessment (e.g., France : CNIL declaration or authorization)
• Lead Regulatory submission activities, coordinate the collection of the documents related to the dossier preparation for submission, QC reviews, etc
• Create and maintain detailed submission plan, KPIs and timelines
• Communication with Health authorities and Ethics Committees ; Responses to requests for information (RFI)
• Preparation and submission of amendments
• CNOM submission / Notifications (France – Sites agreements, Investigators meetings)
• Regulation (EU) No 536/214, Regulation (EU) 2017/745, Regulation (EU) 2016/679  (GDPR), ICH E6 GCP, ISO14155, local regulatory requirements…

Clinical Monitoring & Site Management

Europe (France – Belgium – Switzerland – UK) and North Africa

Need an experienced Clinical Research Associate ?

Our focus is on creating meaningful relationship with sites to ensure efficient conduct of study activities. We work closely with site staff to timely provide the support they need to recruit and retain patients and collect quality data.

• Primary point-of-contact of investigational site personnel
• Site Qualification, Initiation, Interim and Close-out Monitoring visits
• Onsite, remote and centralized monitoring
• Risk Based Monitoring
• Conduct activities in accordance with protocol, SOPs, GCP, GDPR and study requirements
• Day to day management of sites activities: support, supplies, logistics, training, and motivation 
• Patient Recruitment & Retention
• Risk assessment & mitigation
• Data collection & queries management
• Compliance management and Inspection readiness
• Reporting & communication
• ISF / TMF management

Global and Local Project Management

Need an experienced Clinical Study (Project) Manager ?

With deep experience managing cross-functional teams and Vendors, our project management SME provides expertise and support to sponsors in the execution of their clinical research projects in France and globally in different therapeutic areas and clinical development phases from study design to clinical study report authoring and results publication.

Our services are conducted in adherence to the applicable client’s standard operating procedures (SOPs), work instructions, policies, clinical study protocol, Good Clinical Practice (GCP), applicable local regulatory requirements, etc.

• Project planning, conduct, monitoring and reporting
• Development of Study documents, detailed operational plans, and procedures
• Development of investigators and participant materials (welcome pack, newsletter, inclusion/exclusion criteria cards, brochure, etc)
• Vendors selection & oversight
• Cross functional team training & oversight
• Management of clinical trial logistics and supplies
• Management of Stakeholders and KOLs
• Set-up & oversight of committees (e.g., DSMB, CEC, DMC, Scientific Committee)
• Procurements management (including review of contract change orders and ensure services are delivered per contracts terms)
• Study budget and management
• Proactive Risks identification & mitigation
• Audit planning & execution
• Data Review, Reconciliation & Analysis
• Safety Oversight
• Training and Compliance oversight
• eTMF/TMF set-up and inspection readiness
• Data base lock and results reporting
• Project Quality management
  

Supporting continuous improvement of project management processes, driving efficiency and effectiveness in project delivery, and supporting organizations in achieving their strategic objectives and priorities through successful project execution.

Medical Writing Support

We support sponsors with the authoring or revision of clinical trial documents with a keen understanding of regulatory requirements and industry standards, we deliver high-quality, precise, and timely documentation.

We provide expert medical writing services to support sponsors in the development of clinical trial documents. With a deep understanding of regulatory requirements, industry standards and attention to details, we ensure high-quality, precise, and timely documentation.

• Clinical Study Protocol, Synopsis and amendments
• Patient Information Notice, Assents and Consent Form, Diaries, Participant cards…
• Patient recruitment material – Advertisements, brochures, etc
• Study Communication – Newsletters for investigators or participants
• Data Collection Tools – Case Report Form, eCRF / ePRO design
• Investigator Brochure updates
• Study plans & Manuals
• Safety Documents – CEC and DSMB charters, safety narratives, annual safety reports, and annual progress reports
• Clinical Study Report
• Quality Control (QC) Reviews – Ensuring consistency, accuracy, and compliance across all documents

Global or Local Clinical Operations

Need an experienced Clinical Monitoring Lead or Lead CRA ?

• Monitoring SOPs, Monitoring plan and tools
• Risk-based monitoring strategy
• Drive the Clinical Monitoring Team (CRAs, IHCRAs, monitoring CRO/Providers, etc)
• Oversight of the Monitoring CRO and vendors
• Coordination of sites & monitoring activities according to the monitoing plan.
• Review and approve trip reports and follow-up letters within the required timeframe.
• Team Training & compliance oversight
• Co-monitoring visits & CRAs performance assessments
• Schedule and manage regular and ad hoc project team meetings
• Protocol Compliance & inspection readiness
• Communication to all stakeholders on the progress of the study
• Budget & invoicing oversight
• Management of the ISF and TMF (related to clinical operations)
• Data reviews and cleaning activities
• Manage clinical trial supplies including Investigational Products
• Milestones, Metrics, KPIs and Trends review and reporting
• Non compliance management

Safety monitoring & management

We deliver a comprehensive safety services for clinical trials with drugs and medical devices in Europe. Services include:

• Safety data entry, queries and review
• Reconciliation of SAEs
• Individual Case Safety Report (ICSR) management and elaboration of narratives
• Set-up and management of the Data and Safety Monitoring Board (DSMB)
• Set-up and management of the Adjudication Committee (CEC)
• Facilitating meetings and coordination with CEC and DSMB
• Management of Safety vendor
• Annual Safety Report

Blinding / Unblinding

Need an Unblinded team member (e.g., uCRA, uCTM) to assist you with unblinded data monitoring & oversight?

To prevent bias in data collection and analysis, a blinded study may need unblinded study members : unblinded Clinical Trial Manager (uCTM), an unblinded Clinical Research Associate (uCRA)⁠ or an unblinded Clinical Project Manager (uCPM). We can assist sponsors with the monitoring of unblinded data and management of parts of the study that are unblinded. Services include but not limited to:

• Blinding plan and processes
• Review monitoring plan, randomization and/or IVRS specifications and ensure process compliance and risks mitigation
• Review unblinded study data, documents and reports (e.g., safety & dosing, Unblinded Site Monitoring Visit Reports)
• Conduct Unblinded monitoring (on-site or remote) and co-monitoring visits (e.g., pharmacy)
• Assist in Investigational Product (IP) reconciliation, interim analyses, and other unblinding activities requiring reconciliation
• Manage unblinded clinical supplies
• Liaise with the Unblinded committees/teams (e.g., DSMB, PK, medical monitor)
• Ensures proper study document flow and sequestration before study unblinding
• Support the protection and maintenance of the study blind
• Document and report potential/actual unblinding events
• Support the audit response team for findings related to blinded Investigational Product