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    Solutions for the Pharmaceutical and Biotech Industry

    Our Clinical Research team provides extensive and high-quality services for pharma and biotech companies, enabling our customers to bring their products to the market and reach other milestones through clinical trials.

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    We are a full-service and rapid-response Contract Research Organization (CRO)

    We conduct multinational clinical trials for pharma, biotech, and medical device companies across Europe, providing rapid-response, high-quality, and cost-effective clinical trial management services. We have experience with clients of all sizes — from startups to the largest pharmaceutical and biotech companies and academic research institutions. For over 20 years, we have provided our clients with precision and provided flexible solutions that are best suited for your trial needs.

    What we offer for pharmaceutical clinical trials

    With solid experience and an ever-developing service portfolio, we help pharmaceutical and biotech companies as well as academic institutions with complete clinical trials or specific aspects, depending on their needs. 

    Our services as a pharma and biotech CRO include for example:

    Clinical trials management

    • Phase I-IV clinical trials
    • Commercial & non-commercial clinical trials
    • Pre-clinical studies

    Clinical operations

    • Clinical trial monitoring
    • Project management
    • Medical writing 
    • Data management
    • Trial Master File (TMF) management
    • Pharmacovigilance
    • Biostatistical analysis
    • Study plans & document development
    • IMP/IMD storage and logistics coordination

    Regulatory affairs

    • Study submission in accordance with 536/2014, 2017/745 & 2017/746
    • Regulatory strategy planning
    • EU legal representation
    • Clinical trials insurance
    • EMA orphan drug designation

    Site management

    • Extensive clinical research site network
    • Study site initiation and training
    • Study sites selection and Qualification
    • Study sites payment management
    • Study sites contracting
    • ICH-GCP trainings 

    Vendor management

    • Vendor selection and qualification
    • Vendor contracting
    • Vendor oversight

    Equipment rental services

    • Long- and short-term medical equipment rental
    • Centrifuges, freezers, refrigerators, infusion pumps, cardiomonitors, temperature loggers

    How we work

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    Quality

    • Regulatory affairs
    • EU legal representative
    • Quality assurance
    • Orphan drug designation
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    Efficiency

    • Multiple therapeutic areas
    • Medical devices
    • Equipment rental
    • Investigator-initiated trials
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    Timing

    • Recruitment & retention
    • Contracting
    • Grants
    • Outsourcing

    Our experience as a CRO 

    We have over 20 years experience in phase I-IV trials; to date we have worked with several hundred clinical trials. We are experienced in both the commercial and academic studies and have a track record of quality papers and publications. We have proven our capabilities even in very challenging trials.

    We manage the entire clinical trial process

    Trial regulatory affairs and more

    We provide transparent regulatory services.

    Our Regulatory Affairs team has dedicated resources that enable us to provide regulatory solutions to support a wide range of regulatory aspects encountered during preparation and throughout the conduct of each clinical trial.

    • Regulatory strategy & development planning
    • Competent authority and ethical committee submissions and communication
    • Regulatory/GMP compliance

    EU legal representation

    Under the terms of the 536/2014 Regulation in order to conduct clinical trials in the European Union, non-EU-based sponsors must have a European company as their legal representative.

    We offer a contract with Non-EU Sponsors to provide the required legal representative, including the responsibilities of the sponsor with regards to GCP and regulatory compliance.

    Contact us for more information

    Meeri Säily
    Meeri Säily
    Sales Director, Consulting and Clinical Trials

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