Clinical Research Consultant

Dr. Roger Dallwig has been working in the field of clinical research since June 2001. In his previous appointments he has been responsible for all aspects of clinical monitoring in accordance with national drug and medical device laws, European directives and regulations, company SOPs, ICH-GCP, ISO 14155, and FDA regulations.
He has been involved in the writing of study protocols, the design of CRFs, submissions to IECs/IRBs and regulatory authorities (throughout Europe), recruitment of investigational sites and in the support of clinical database validation programming.
Since June 2001 he has participated as a CRA or Lead CRA in drug (phases II - IV) as well as medical device studies. In the context of these he has attended numerous training sessions (e.g. general pharmacology, pharmacokinetics, ECG interpretation and disease management seminars). The mentioned studies were conducted in EU countries either on both standard and special populations (e.g. elderly, renal or hepatic impaired patients).
In addition to the above, he has been responsible as a Junior Project Manager for studies in the indications hypercholesterolemia and pulmonary hypertension. As part of his duties as PM and Lead CRA he successfully performed trainings of CRAs, and was involved in negotiations with third-party vendors and CROs.
Since April 2004, R. Dallwig has been working as a freelance clinical research consultant. He is responsible for in-house, remote, and on-site monitoring activities as well as for submissions to IECs/IRBs and regulatory authorities. Other services provided are: GCP and regulatory training, medical writing and in-house support to study-related activities.
On 20 April 2020 he has been accredited by the International Accrediting Organization for Clinical Research (IAOCR) and has achieved the “Qualified Clinical Research Monitor Certification (MIACR)”