Clinical Trial Consulting Services

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 : Optimize Your Clinical Trial Success

Need an experienced Clinical Trial Feasibility Specialist ?

A comprehensive feasibility assessment is a critical first step in ensuring clinical trial success. A well-executed feasibility study enhances site selection, streamlines recruitment, and mitigates risks—ultimately improving study outcomes.

We provide expert oversight and coordination of feasibility assessments to optimize country & site selection while maximizing trial success.

Our Feasibility Services Include:

• Feasibility Strategy & Planning
• Comprehensive Clinical Study Feasibility Assessment
• Study-Specific Documentation (feasibility questionnaires, cover letters, and more.)
• Optimal Country & Site recommendation – Site identification & qualification
• Regulatory & Ethical requirements and overall approval timelines
• Strategic Planning, incl. timelines, risks, recruitment projections, milestones and resource allocation
• Study Design and Protocol Review (e.g., Expert feedback to refine protocol)

Study Start-Up : Accelerate Your Clinical Trial Success

Need an experienced Start-Up Expert or Site Activation Manager?

Study start-up is one of the most critical phases of a clinical trial because it lays the foundation for success. The quality and efficiency of start-up directly impact the timelines, budget, compliance, and overall study outcomes.

Our expert provides strategic support and leadership in all aspects of study start-up and site activation ensuring efficient timelines and a robust regulatory strategy.

Our Study Start-Up Services Include:

• Targeted Site & Investigator Identification, qualification and selection (incl. KOLs)
• Study-Specific Documentation (study operational plans, monitoring procedures, checklists, etc.)
• Regulatory Authorities & Ethic Committees Submissions and Communication
• Resources Allocation
• Services providers selection and oversight (including, RFP development, specifications and budget analysis, Bid defense, etc.)
• Timelines and Budget Management
• Risks Mitigation Strategies
• Contracts Negotiation and Management (Suppliers and Sites agreements)
• eTMF/TMF Set-up and Essential Documents Management

Regulatory Submission : Ensure Compliance, Minimize Delays

Need an experienced Regulatory Specialist or Submission Manager?

We provide expert regulatory support to streamline clinical trial approvals and prevent delays. With extensive experience in clinical trial submissions across diverse programs—including drugs, medical devices, vaccines, drug-device combinations, and licensed substances, we guide you through evolving EU regulations and optimize your submission strategy.

Our Study Regulatory Services Include:

• Regulatory Strategy & National Requirements Guidance (with support of our network of consultants and partners in EU & USA)
• Scientific Advice & Pre-Submission Meetings Coordination
• Regulatory Package Preparation – incl. Adaptation of trial documentation to local requirements (e.g. Synopsis, Patient Information Notice and Informed Consent Form, Patient’s recruitment material, labels, insurance, translations)
• Regulatory submission to Health authorities and Ethics Committees (e.g., CTIS Part I & CTIS Part II)
• GDPR Compliance
• Import/Export License Applications
• Regulatory Submission Coordination & Oversight (Coordinate CTA preparation, document collection, QC reviews, tracking, KPIs, etc)
• Communication with Health authorities and Ethics Committees (e.g., Responses to requests for information (RFI))
• Amendment Preparation & Submission
• Other local Regulatory obligations : e.g., CNOM submission / Notification of Sites agreements and Investigators meetings, CNIL declaration / authorization, Health Data Hub.
• Post-Approval Activities ensuring compliance with post-approval obligations
• Regulation (EU) No 536/214, Regulation (EU) 2017/745, Regulation (EU) 2016/679  (GDPR), FDA regulations, ICH E6 GCP, ISO14155, local regulatory requirements…

Clinical Monitoring & Site Management : Ensuring Ethical, Safe, and Compliant Trials

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.

Our monitoring Services Include:

• Onsite, Remote and Centralized monitoring
• Site Qualification, Initiation, Interim and Close-out Monitoring visits
• Primary point-of-contact for investigational site personnel
• Regulatory submissions
• Contract Negotiation & Invoicing Oversight
• Risk Based Monitoring
• Compliance with protocol, SOPs, GCP, GDPR, applicable regulations and study requirements
• Site Management & Support – Supplies, Logistics, Queries, Training, and Engagement
• Patient Recruitment & Retention Support
• Proactive Risk Assessment & Mitigation
• Data Collection & Queries Resolution
• Compliance Management and Inspection Readiness
• Support Sites before and during audit and Inspection
• Reporting & Communication
• ISF / TMF management & Inspection readines
• Regions Covered : English & French speaking countries in Europe (Belgium – France – Ireland – The UK – Switzerland), Middle-East, Africa and beyond.

Project Management : Driving Excellence in Clinical Trial Execution

Need an experienced Clinical Study (Project) Manager ?

With deep experience managing cross-functional teams and Services Providers, our project management SME supports sponsors in executing clinical research projects across France and globally. We manage studies across various therapeutic areas and development phases, ensuring efficient execution from study design to results publication.

All services are conducted in adherence to client SOPs, study protocols, GCP, and regulatory requirements.

Our Project Management Services Include:

• Project Planning, Execution, Monitoring & Reporting
• Study Document & Operational Plan Development
• Regulatory Submission Coordination – Supporting timely submissions & compliance tracking
• Site Selection & Patient Enrollment Oversight – Monitoring recruitment & site activation
• Vendor & Stakeholder management – CROs, labs, imaging, and investigator relationships
• Resource allocation & team management – Oversight and communication
• Clinical Trial Logistics & Supply Chain management
• Risk assessment, tracking, escalation and management – Proactive issue resolution
• Audit Planning, Execution & Inspection Readiness
• Protocol Compliance & Deviation Oversight – Mitigating risks & ensuring adherence
• Data Review, Reconciliation & Database Lock Oversight
• Study Budget & Contract Management – Vendor qualification, performance review & cost control
• Safety Oversight & Quality Management – Ensuring trial integrity & adherence to GCP
• Clinical Study Report (CSR) & Results Submission
• TMF set up, management and Inspection readiness
• Management of overall project timelines and deliverables
  

Medical Writing : Clear, Precise, and Compliant Documentation

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

Our Medical Writing Services Include:

• Regulatory & Research Documents
  • Protocol writing and expert review of phase I, phase II, phase III and phase IV clinical studies, including protocol amendments
  • Investigator Brochure (IB) amendments
  • Participant Information Notice, Assents and Consent Form writing and expert review
  • Other Patient Facing Documents: Diaries, Participant card, Patient’s Recruitment Material (advertisement, brochure…)
  • Data Collection Tools – Case Report Form (CRF), eCRF & ePRO Design
  • Clinical Study Report (CSR) writing in compliance with ICH GCP guidelines and review
• Study Communication – e.g., Newsletters for investigators & participants, Slide presentations
• Study plans & Manuals
• Safety Documents – CEC & DSMB charters, safety narratives, annual safety reports, and progress reports
• Quality Control (QC) Reviews – Ensuring accuracy, regulatory compliance and consistency across all documents

Clinical Operations

Need an experienced Global or Regional Clinical Monitoring Lead / 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.
• Recruitment planning and tracking
• Therapeutic area, Protocol and project-specific training material development
• Organization of investigators meetings
• 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
• SAE Reconciliation
• Individual Case Safety Report (ICSR) management
• Query resolution to case closure
• Set-up and management of the Data and Safety Monitoring Board (DSMB)
• Set-up and management of the Adjudication Committee (CEC)
• Preparation of case narratives
• Facilitating meetings and coordination with CEC and DSMB
• Management of Safety vendor
• Expedited SUSAR and Annual Safety Report notification to health authorities & Ethics Committees

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

Direct-to-Patient Services : Reducing site burden, improving retention

We offer comprehensive clinical trial direct-to-patient services to support sponsors conducting clinical trials in France. Our services are designed to ease site burden, reduce barriers to trial participation, enhance participant’s engagement and ensure regulatory-compliance.

Participant’s Reimbursement & Payment

Sponsors may reimburse eligible expenses incurred by participants during their participation in a clinical trial. The reimbursement process must be documented and approved by the Ethics Committee before implementation, ensuring compliance with Good Clinical Practice (GCP) and applicable regulations.

We ensure efficient, transparent, and GCP-compliant reimbursement process while maintaining strict data privacy and adherence to regulatory requirements.

• Reimbursement to Research Subjects of approved out-of-pocket expenses related to trial participation such as mileage, meals, and transportation. 
• Per Diem Payment – Fixed compensation to patients when applicable.
• Data-Triggered Payment – Reimbursement is processed upon verification of patient visits and submission of required receipts or a completed reimbursement form.
• Mileage Calculation – Round-trip mileage is typically calculated using Google Maps, based on the subject’s home address and the study site location. Reimbursement is provided at the applicable rate.
• Regulatory Compliance – Adherence to the reimbursement Policy, approved Study Protocol and Informed Consent Form, GDPR, CNIL Reference Methodology, and applicable regulations.

Standard Reimbursement Workflow:

1. Participant Data Collection – Personal data is collected from study sites.
2. Proof of Expenses – scan of receipts / reimbursement form are collected from study sites / Participants
3. Verification & Processing – Study data is received from the sponsor or designee, and expenses are verified.
4. Timely Payment to participant – Reimbursement is promptly issued following verification.
5. Reporting – Sponsor receives monthly reports while ensuring data privacy.

Participant’ concierge service

We can also support sponsors with travel logistical and assistance to facilitate patient’s participation in clinical trials, reducing site burden and improving accessibility.

Comprehensive Travel Support:

• Ground, Air & Rail Travel : Coordination of mobility assistance and medical transport for participants requiring special accommodations.
• Hotels & Long-Term Housing : – Securing suitable overnight lodging or extended-stay housing solutions.

Decentralized Clinical Trials (DCTs)

Decentralized Clinical trials (DCTs) involve conducting some or all trial-related activities at locations other than traditional clinical trial sites, such as participants’ homes or local healthcare facilities that are convenient for the participant. This approach aims to enhance participant accessibility and convenience.

Why Decentralized Clinical Trial ?

• The ICH E6(R3) guideline promotes flexibility and encourages the adoption of innovative trial designs, including trials with decentralized elements, to improve trial efficiency and participant engagement while maintaining high ethical and scientific standards
• The COVID-19 pandemic and advancements in digital health technologies created unprecedented opportunities for the implementation and integration of decentralized elements into clinical studies enabling greater patient-centricity and operational efficiency.
• Clinical trial participants prefer receiving treatments at home or at their local clinic, rather than travelling long distances to a traditional clinical trial site. 

Advantages of a DCT :

• Faster Recruitment – Expands the patient pool, leading to quicker enrollment.
• Increased Accessibility and Diversity – More representative populations due to reduced geographic and economic barriers.
• Enhanced Patient Retention & Engagement – Less inconvenience and more flexibility for participants lead to higher retention and better satisfaction
• Improved data quality – Helps prevent missing data
• Reduced burden on healthcare facilities.
• Accelerated timelines: DCTs are associated with shorter timelines of trial delivery leading to cost reduction

Key Features of DCTs:

1. Remote Data Collection – Leveraging digital tools like mobile apps, wearables, and online surveys.
2. Telemedicine Visits – Participants engage with investigators via video calls instead of frequent in-person visits.
3. Home-Based Sample Collection – certified Nurses may collect blood samples and other biological specimens at the participant’s home.
4. Direct-to-Patient Drug Shipment – Investigational products or study materials can be delivered directly to participants.
5. Reduced Site Visits – Minimizes travel burden, making participation more accessible and convenient.

Our DCT services in France

We offer specialized support to sponsors conducting decentralized trials in France, ensuring regulatory compliance and efficient trial execution.

• Home Care Nursing – Identification, qualification, and contracting of suitable home care nurses for each participant based on location.
• Training & Oversight of Home Nurses – Ensuring study home nurses are well-prepared and compliant with all trial protocol specific procedures as well as GCP-compliant documentation.
• Study Document Preparation – country specific adaptation and translation of study material
• Informed Consent Process – Support the design and implementation of informed consent process (eg., electronic Informed Consent)
• Regulatory Submission – Assistance with ANSM, CPP, CNIL and CNOM submissions.
• Communication plan development – Co-ordinate optimal communication process between sponsor, sites, home nurses, and involved service providers.
• Home visits – Home care nurse can collect biological samples, administer treatment, record vital signs, perform IP accountability, check compliance, monitor adverse events…. in line with the study protocol
• Logistics & Direct Shipment – Organizing and tracking home delivery of IP and non-IP supplies, assist with samples shipment to the central laboratories, coordinating IP return from the trial participant’s home to depot, ….and with reconciliation activities.
• Direct Data collection and Management – support sponsors and investigators in collecting reliable study data while ensuring patient safety, data integrity, and privacy compliance.

Why Work with Us?

Deep Expertise in Clinical Operations & Regulatory Requirements – Ensuring full compliance with local and international regulations.

Patient-Centric Approach – Enhancing retention and engagement through seamless support services.

Optimized Trial Execution – Reducing trial timelines and costs while maintaining high data quality.

Personalized clinical research services – supporting you with flexibility, dedication, and accountability across every stage of your clinical development journey.