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CYNCRON

Clinical Research, Data Management, Biostatistics, Pharmacovigilance and DMC/DSMB Services

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CYNCRON

CYNCRON is a Nordic full-service Clinical Research Organization (CRO) with more than 25 years of experience, operating throughout the Nordic Region (Denmark, Sweden, Finland and Norway). We offer solid know-how and experience of clinical research, data management, biostatistics, pharmacovigilance and DMC/DSMB services for global and small pharma, biotech and medical device companies.

At CYNCRON we are experts in interacting with Nordic regulatory authorities, meaning fast submission and short approval times. We generate High Quality Data, i.e. data generated in the Nordic Region are received very well by EMEA and FDA. CYNCRON covers the full range of CRO services throughout your products’ lifecycle, for studies of all sizes and through all phases and beyond, acting either as a full-responsibility partner or provider of in-sourced expertise.

The CYNCRON team is dedicated and professional, with a wide range of academic competence and solid experience of clinical research, as well as of working with global pharmaceutical, biotech, medical device companies and of interacting with the various regulatory authorities in the Nordic region. We have a flexible approach and value relationships based on trust. Please ask for references – We will be happy to supply this at any time.

Clinical trial management, data management, biostatistics, pharmacovigilance and medical affairs services

We cover the full range from single-centre to multi-national projects, offering professional clinical trial management, data management, biostatistics, pharmacovigilance and DMC/DSMB services for pharmaceutical, biotechnology and medical device companies. We can manage your project from start to finish, or function as a fully-integrated part of your study team.

At CYNCRON, we are aware of the fact that our customers need to cut timelines and be cost-effective when bringing an investigational product up to registration. In all Nordic countries, we have experienced native-speaking experts handling all regulatory and ethical submissions, as well as local monitoring services and support-to-site. This, together with an excellent network of local investigators, speeds up the regulatory process, as well as facilitating communications with sites and investigators.

We conduct all our work according to current regulations and guidelines i.e. ICH-GCP, local ethical requirements and Sponsor or CYNCRON SOPs. Being a local Nordic CRO, we can provide you with our wide-ranging knowledge on local networks, including investigators, both within the private sector and in state-run institutions.

www.cyncron.com

Cyncron A/S
Teglgaarden 60
DK-3460 Birkeroed
Denmark
Tel: +45 7020 2058
Cyncron AB
Isafjordsgatan 22B
SE-164 40 Kista
Sweden
Tel: +46 8 751 10 80
Cyncron OY
Metsänneidonkuja 10
OY-02130 Espoo
Finland
Tel: +358 7255 4400

Data Monitoring Committee

The Data Monitoring Committee (DMC) Group is a separate unit at Cyncron specialised in facilitating the establishment of DMCs, DMC meeting logistics and DMC memberships.

Cyncron DMC Unit offers the following services: Setting up a DMC with a charter Negotiating individual contracts with DMC members Ensuring that there will be no conflicts of interest Gathering all data input and producing data packages Sending out a data package one week prior to the meeting DMC meeting logistics (meeting invitations, travel arrangements,…

Medical Affairs

To supplement your clinical research needs, Cyncron can also assist you in medical affairs

Medical writing With our vast experience in clinical research, the medical writers at Cyncron can assist both large pharmaceutical and smaller biotech companies with the preparation of clinical development plans and protocols, investigator's brochures, integrated clinical trial reports, safety summaries and clinical expert summaries. To provide you with optimal patient access, Cyncron is continuously expanding…

Quality Management

Quality Management (QM) is an independent unit at Cyncron. From early study synopsis to final reporting QM assures that all quality aspects are adhered to at Cyncron.

They secure full compliance with regulatory requirements, Cyncron and Sponsor Standard Operating Procedures (SOPs) and ICH Guidelines. In addition, Cyncron QM offers a variety of services to clients: GCP audits: Sponsor company - e.g. system audits, trial audits of sponsor suppliers and audit of IT systems Investigational sites QA consultancy and support sponsor staff in:…
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