Help centre
Clear answers to support your clinical projects
For more than 15 years, Pharmaspecific has supported sponsors, biotechs, medical device manufacturers and investigator sites. Here you will find answers to the most frequently asked questions about our services and expertise.
General questions
A CRO (Contract Research Organization) is a company specialising in supporting sponsors in the conduct of their clinical trials and clinical investigations. CROs provide regulatory, operational and scientific expertise to secure and optimise the delivery of research projects.
Pharmaceutical companies, biotechnology companies, medical device manufacturers, healthcare institutions, investigator sites and academic sponsors in France and internationally.
In France, Europe and internationally, through a network of experienced partners and experts.
Phase I to IV clinical trials, medical device clinical investigations, observational studies, real-world studies and post-marketing projects.
Clinical services
Clinical project management, Clinical trial monitoring, On-site coordination (CRC), Regulatory affairs, GCP compliance audits, Patient expense management, Patient concierge support, Medical writing, Clinical research training, EU legal representation.
Yes, our services are fully modular, available on a one-off basis or as end-to-end support.
Yes, through our qualified staff provision services.
Yes, our auditors support the assessment of compliance with Good Clinical Practice (GCP).
Patient solutions
We administer reimbursements according to the rules defined by the sponsor and applicable regulations.
Yes.
Yes, to make it easier for patients and sites in different countries to use.
Arranging the travel, accommodation and services needed for participants to attend study visits.
To reduce the logistical burden on participants and limit the risk of dropouts during the study.
Regulatory affairs and medical devices
Yes, in accordance with the European MDR and IVDR regulations.
Yes, for sponsors established outside the European Union.
Good Clinical Practice (ICH-GCP), European medicinal product regulations, and the MDR and IVDR regulations.
Training
Yes, for investigators, CRAs, CRCs and project managers.
Yes, in person or remotely via our dedicated training platform.
Yes, it is adapted to the specific needs of each organisation.
Yes.
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Contact usClear answers to support your clinical projects
For more than 15 years, Pharmaspecific has supported sponsors, biotechs, medical device manufacturers and investigator sites. Here you will find answers to the most frequently asked questions about our services and expertise.
GENERAL QUESTIONS
What is a CRO?
A CRO (Contract Research Organization) is a company specialising in supporting sponsors in the conduct of their clinical trials and clinical investigations. CROs provide regulatory, operational and scientific expertise to secure and optimise the delivery of research projects.
What types of clients does Pharmaspecific support?
Pharmaspecific supports pharmaceutical companies, biotechnology companies, medical device manufacturers, healthcare institutions, investigator sites and academic sponsors in France and internationally.
What types of studies can you support?
We work on Phase I to IV clinical trials, medical device clinical investigations, observational studies, real-world studies and post-marketing projects.
CLINICAL SERVICES
What services does Pharmaspecific offer?
Our services include:
• Clinical project management
• Clinical trial monitoring
• On-site coordination (CRC)
• Regulatory affairs
• GCP compliance audits
• Patient expense management
• Patient concierge support
• Medical writing
• Clinical research training
• EU legal representation
• Clinical project management
• Clinical trial monitoring
• On-site coordination (CRC)
• Regulatory affairs
• GCP compliance audits
• Patient expense management
• Patient concierge support
• Medical writing
• Clinical research training
• EU legal representation
Can you work on just one part of a project?
Yes. Our services are fully modular and can be provided on a one-off basis or as part of end-to-end support.
Do you have resources that can be integrated directly into project teams?
Yes. We provide qualified staff to strengthen the teams of sponsors or investigator sites.
Do you carry out GCP compliance audits?
Yes. Our auditors support sponsors and investigator sites in assessing their compliance with Good Clinical Practice (GCP).
PATIENT SOLUTIONS
How does your patient expense management service work?
We administer the reimbursement of expenses incurred by clinical study participants according to the rules defined by the sponsor and in compliance with applicable regulations.
Does your reimbursement solution comply with European regulations?
Yes. Our platform was designed to meet the European regulatory requirements applicable to reimbursing clinical study participants.
Is your reimbursement platform available in several languages?
Yes. Our solution is available in several languages to make it easier for patients and investigator sites in different countries to use.
What does the patient concierge service include?
The concierge service arranges the travel, accommodation and services patients need to attend study visits, helping to improve their experience and retention.
Why do sponsors set up patient concierge services?
These services reduce the logistical burden on participants, make it easier for them to attend the visits required by the protocol and limit the risk of study dropouts.
REGULATORY AFFAIRS AND MEDICAL DEVICES
Do you support medical device clinical investigations?
Yes. We support medical device manufacturers in conducting their clinical investigations in accordance with MDR and IVDR requirements.
Can you act as a legal representative in Europe?
Yes. Pharmaspecific acts as legal representative for sponsors based outside the European Union who wish to conduct clinical studies in Europe.
Which regulations do your teams cover?
Our experts support projects subject in particular to Good Clinical Practice (ICH-GCP), the European regulations applicable to medicinal products, and the MDR and IVDR regulations.
TRAINING
Do you offer clinical research training?
Yes. Pharmaspecific offers training for investigators, CRAs, CRCs, project managers and other professionals involved in clinical research.
Can training be delivered remotely?
Yes. Training can be delivered in person or remotely through our dedicated training platform.
Can training be customised?
Yes. Our programmes can be adapted to each organisation's procedures, operational needs and skills development objectives.
Are you Qualiopi-certified?
Yes. Pharmaspecific holds Qualiopi certification for its training activities, attesting to the quality of our training processes.
A question about your project?