Who we are
The consultancy Trial-Support was started and is owned by Clinical Research Manager Kjeld Clemmensen-Rotne.
Based on national and international experience from many years of working with clinical research as well as marketing activities in the medical industry, the consultancy Trial-Support is able to carry out a wide range of tasks related to clinical research and to communicate the knowledge gained.
Our main experiences is in Gastroenterology and Oncology, but other areas of pharmacology and therapeutics are also covered by Trial-Support.
A great network of relationships has been built up within clinical research units in the health sector, in the medical industry and in Contract Research Organisations (CRO) during the last decades of working with clinical trials.
Our objective is to be a support of great value for the promotion of clinical research and for the best possible communication of the scientific knowledge gained.
The use of video systems for documentation, research and educational activities have been growing rapidly during this century.
In Denmark we have been the local contact for the Norwegian Company POSICOM and their unique video multi-media system Seekuence®, Since 2015.
Seekuence®Medical for the health sector and Seekuence®Inspection in relation to maritime and marine activities.
And what we can do
Trial-Support is a Company that offers flexible solutions for clinical research and for the health care industry – for part or entire projects.
Trial-Support can be the extra resource necessary for clinical research organisations (CRO) or for expanding companies to reach a target in due time.
Trial-Support can be the qualified support for clinical research units and for the country coordinating sites and investigators in investigator-initiated clinical trials.
Development of teams and team-coaching is one of our related skills to the clinical trials, to ensure a superior performance.
Fundraising is another of our related skills in clinical research, a task that has become increasingly necessary especially in investigator initiated clinical trials.
To ensure sufficient capacity and the best specialised knowledge and expertise tailored for major projects, Trial-Support collaborates with partners from our network.
From the very beginning of your trial to the final communication of the results, Trial-Support is a qualified resource ready to run your specific task.
Jeg er født den 30. januar 1948 i København
Spændvidden i mit hidtidige erhvervsforløb går fra uddannelse indenfor byggeri efterfulgt af medicinstudiet på Københavns Universitet, salg og marketing i medicinalindustrien til Klinisk Forskningskoordinator med projektledelse af kliniske forsknings opgaver. I 2008 startede jeg konsulentfirmaet Trial-Support der varetager opgaver indenfor klinisk forskning.
Kombinationen af klinisk forskning og markedsføring har givet mig en stærk profil indenfor kommunikation og videns formidling via forskellige medier og til vidt forskellige persongrupper. Møder, undervisning eller formidlingen af data fra forskningen er foregået både i større fora og for mindre grupper tilpasset den aktuelle situation og målgruppe.
Deltagelse i nationale og internationale kongresser, symposier og kurser arrangeret af vidt forskellige faggrupper har sikret en løbende opdatering af den nødvendige ekspertise i relation til forskningsopgaverne.
Funktionen som Klinisk forskningskoordinator har krævet at man kan arbejde særdeles selvstændigt med mange projekter samtidig og som projektleder. Systematik, høj kvalitet og kravene til dokumentation er jeg blevet trænet grundigt i under de mange år med sundhedsfaglig forskning. Mange af projekterne har jeg været ansvarlig for fra ide til publikation.
Mit mangeårige virke hos AstraZeneca A/S har været meget alsidigt og meget selvstændigt. Det har bestået af tværfagligt samarbejde med mange forskellige faggrupper, nationalt såvel som internationalt. Initiativer i form af teambuilding, opbygning af workshops og fokus- grupper har bidraget både med innovation og den nødvendige dynamik i de forskellige projekter og kampagner. Konkurrencen indenfor medicinalindustrien af en sådan karakter, at det at være resultatorienteret er blevet et helt naturligt element i relation til de daglige opgaver.
Omdrejningspunktet i mit arbejde har altid været kundekontakter og kontakter til samarbejdspartnere med vidt forskellige baggrunde og i meget forskellige situationer. Opbygning af relationer og netværk både internt i firmaet og i branchen samt eksternt blandt forskningsenheder og i sundhedssektoren som helhed, har været en uvurderlig inspirationskilde og det bærende element i mit virke.
Med etableringen at konsulentfirmaet Trial-Support ønsker jeg nu at bygge videre på de mange års erfaringer inden for klinisk forskning, formidling af viden og udvikling af uddannelser, samt at vedligeholde og udbygge mine kompetencer og mit netværk indenfor Sundhedssektoren. Med etableringen af samarbejdet med det Norske firma Posicom og deres unikke videosystemer kan både forskningen og udviklingen af uddannelser få helt nye dimensioner både indenfor Sundhedssektoren og desuden også indenfor de maritime områder.
I was born in Copenhagen January 30th 1948.
I started my professional education at basic schools for resident engineers in Copenhagen followed by employment at the property development company Jensen & Timmermann as an assistant supervisor during the building of Domus Vista and Domus Park in Copenhagen. This job gave me an initial training as team leader and inspired me to aim at a higher education.
My medical education began at the University of Copenhagen and continued afterwards for more than three decades during my employment at the medical company AstraZeneca A/S, where I completed several internal and external courses supplemented by field training in Dermatology and Gastroenterology.
In relation to internal promotion, I combined my basic medical education with marketing activities and thus trained my skills in communication, teaching, meeting performance and creation of different kind of workshops for a great variety of professions and in forums of many dimensions. The strong competition in the medical industry has strengthened my attention to always be at the leading edge of management to reach targets in due time.
Very early in my career as a CRA (Clinical Research Associate) in the medical department of AstraZeneca A/S, I was given the responsibility for the clinical trials program in Denmark of the first proton pump inhibitor, Omeprazole, for treatment of acid related diseases. In my work as national clinical project manager for all the gastrointestinal clinical trials, I have come to master many different technical skills which I have learned from interdisciplinary international cooperation with various groups of professions. These skills include teambuilding and coaching to ensure a superior performance of the clinical trials and the best diffusion of the scientific knowledge gained.
Customer care and building networks with different collaborators have always been the pivotal points in my life with clinical research and marketing activities. Based on my network, which has been built through decades of work in the health sector, the medical industry and research units, I have decided to continue devoting my time to clinical research and development of educational activities. In collaboration with the Norwegian Company Posicom and their innovative video multi-media system for the healthcare sector and in relation to maritime and marine activities, I have since 2015 been able to add this unique modern technic to many of my activities and to expand the knowledge of these new possibilities.
By my consultancy Trial-Support, I wish to utilize all my experience gained and to continue the progress of my education and skills.
Thus to expand knowledge, research is still my guiding star!
SURNAME: | Clemmensen-Rotne |
FIRST NAME: | Kjeld Monrad |
DATE OF BIRTH: | January 30, 1948 |
CITIZENSHIP: | Danish |
PRESENT POSITION: | Clinical Research Manager Business Coach Managing Director and owner of Trial-Support (www.Trial-Support.eu) |
EDUCATION: | Medicine at University of Copenhagen 1970 – 1974 LIF 1975 (LIF: The Swedish Association of the Pharmaceutical Industry) MEDIF 1976 (MEDIF and LIF: The Danish Association of the Pharmaceutical Industry) LIF diploma degree in GCP-monitoring 2002 LIF diploma degree in research methodology and statistics 2003 LIF diploma degree in Pharmacology 2005In the attached Enclosure are listed all courses, congresses or other activities of educational value during more than 33 years employment by AstraZeneca and during the time of my consultancy Trial-Support. |
PREVIOUS POSITIONS: | Astra Zeneca A/S: Medical Representative 1975 – 1978 Product Specialist 1978 – 1981 Product Manager Deputy 1981 – 1982 Product Manager 1982- 1983 Clinical Research Manager 1983 -2008 |
PUBLICATIONS: | For details, see Enclosure |
MEMBERSHIPS: | Danish Society of Gastroenterology and Hepatology (DSGH) Danish Society for Good Clinical Practice |
DATE OF ISSUE: | 2016-06-06 |
Enclosure to the Curriculum Vitae for Kjeld Clemmensen-Rotne
Clinical Project Manager at AstraZeneca A/S for the clinical trials in Denmark with omeprazole and other gastrointestinal pharmaceuticals from 1983 to 2008.
More than 70 clinical trials with omeprazole, esomeprazole and budesonide have been performed including many investigator initiated trials.
Clinical Project Manager at Astra Zeneca A/S for KVALIMED, a quality developing project in psychiatry in Denmark, 2006 – 2007.
AstraZeneca courses:
- Introduction to Clinical Trials
- Clinical Trial Methodology from Statistical Point of View
- Management Seminar I
- First Astra Quality of life Seminar
- AE coding in AMOS
- Editing and Source data Verification
- PH-Clinical
- COOL Training (web based data capture program for clinical data)
AstraZeneca product training courses within:
- Gastroenterology
- Dermatology
- Glaucoma
- Rheumatology
- Gallstones
- Neuroscience
Other courses:
- Evaluation of Drugs, The Royal Danish School and Pharmacy
- Dermatology, MEDIF
- Gastroenterology, MEDIF
- Communication skills (Transaction analysis) Management Consult
- Gastrointestinal Endoscopy, Scandinavian Association for Digestive Endoscopy (SADE)
- Medical Research Methodology, DADL
- How to perform a presentation, PRACTICA
- ST3 Statistics – SPSS/PC 1, Basic course, UNI-C
- Pharmacokinetic, Danish Society of Clinical Pharmacology
- Scientific Fraud, Professor Poul Riis, University of Copenhagen
- Clinical Trials – from pre-clinic to publication, Research and Development Foundation, University of Copenhagen
- Research in Primary Care, New Strategies – New Methods, UK/Nordic Workshop, Copenhagen
- To write and publish a scientific paper, University of Copenhagen
- Statistical Methods, Danish Society of Clinical Pharmacology
- How to negotiate, AMPHION
- Elimination of Drugs, Danish Society of Clinical Pharmacology
- Laparascopic Surgery , Odense University Hospital
- Train the trainer, PHASE-FORWARD (InForm, web-based data capture program for clinical data)
- Project Management, Ledernes Kompetence Center
- Sales and Marketing Methods, Blachman Sales Academy
- DGS; In-service course, Gastroenterology, January 2009 and 2010
- Business Coaching, Københavns Erhvervsakademi
- DSGH; In-service course, Gastroenterology, January 2013
- LIF Education; Legislation in Clinical Research, Updating and Interpretation (2014)
- LIF Education; Non-Interventional Studies
- LIF Education; Introduction to Drug Safety & Pharmacovigilance
- LIF Education; Legislation in Clinical Research, Updating and Interpretation (2015)
Furthermore I have participated in several internal/external courses and workshops during the 33 years employment at AstraZeneca A/S about items as, selling, communication, management, meeting performance, conduct of clinical trials, teambuilding, coaching, gastroenterology, dermatology, psychiatry, glaucoma pharmacology, statistics and AstraZeneca SOP´s and Guidelines in relation to clinical trials.
Hospital Field-training:
Gastroenterology at Odense University Hospital,
/Dr. Karsten Lauritsen MD
Dermatology at Odense University Hospital,
/Professor Henning Schmidt
Participation in International Congresses:
Gastroenterology:
More than 30 during my employment as Clinical Research Manager, AstraZeneca A/S
(American Gastrointestinal Association/DDW x 13, always in relation to one or more presentations)
Nordic Digestive Week, 41st Nordic Gastroenterology Congress, Copenhagen 2010
ECCO’14 Copenhagen Congress
Gastrointestinal Cancer:
ESMO 13th World Congress on Gastrointestinal Cancer, 2011
ESMO 14th World Congress on Gastrointestinal Cancer, 2012
ESMO 15th World Congress on Gastrointestinal Cancer, 2013
ESMO 16th World Congress on Gastrointestinal Cancer, 2014
ESMO 17th World Congress on Gastrointestinal Cancer, 2015
ESMO 18th World Congress on Gastrointestinal Cancer, 2016
ESMO 19th World Congress on Gastrointestinal Cancer, 2017
ESMO 20th World Congress on Gastrointestinal Cancer, 2018
Pediatric:
Toulouse, 1998
Dermatology:
1982 Copenhagen
Participation in Symposia:
- Ulcer and the treatment, Mölndal 1979
- International Symposium on Antacids, Gothenburg 1981
- Dyspepsia, Vejle 1982
- Sympathetic Influence on Gastric Function, Copenhagen 1983
- Symposium on Dyspepsia, Hyvinkää 1984
- The First International Symposium on Omeprazole, Algarve 1984
- The International Symposium on Omeprazole, Monaco 1988
- Emerging Strategies in the Management of Acid-Related Diseases, Paris 1993
- The First European Primary Care Gastroenterology Meeting, ”Managing Acid-Related Diseases” (Interactive Clinical Seminar), Schevingen, Holland April 1994
- The pH-Hp Challenge From Mechanism to Management, Copenhagen 1995
- IBD, The Patient in Focus, Lund 1996
- Omeprazole, NSAID, Stockholm 1996
- Consolidating the Advances in IBD, Prague 1997
- Crossing Borders in the IBD, Barcelona 1998
- pH-Hp, Implications for Dyspepsia Management, Geneva 1998
- Reflux Disease, Pathways to Best Care, Cologne 1999
- Nexium, First International Symposium, San Francisco 2000
- Advanced Treatment of Chronical Inflammatory Bowel Diseases, 2009
- SAGIM; Nutrition, Copenhagen 2011
- Endoscopic Treatment of Pre-Malignant and Malignant Lesions in the GI Tract, International Symposium, 2013
- LIF Education; Meeting about KRIS
- KFFB, Krebsforschung Fehmarnbelt, Meeting and Conference in Lübeck, 2013
- Upper GI Cancer, Copenhagen 2013
- Upper GI Cancer, Copenhagen 2014
- Upper GI Cancer, Copenhagen 2015
- Post ASCO by SKA, Copenhagen 2015
- Danish Colorectal Cancer Symposium, Copenhagen 2015
- Danish Colorectal Cancer Symposium, Copenhagen 2016
- Post ASCO by SKA, Copenhagen 2016
- Upper GI Cancer, Copenhagen 2016
- Post ASCO by SKA, Copenhagen 2017
- Upper GI Cancer, Copenhagen 2017
- Post ASCO by SKA, Copenhagen 2018
- Upper GI Cancer, Copenhagen 2018
- Post ASCO by SKA, Copenhagen 2019
- Upper GI Cancer, Copenhagen 2019
- Upper GI Cancer, Copenhagen 2021
Publications and Acknowledgements:
- Co-author: Gastroenterology 1989; 96: A204, omeprazole in patients with PSS
- Co-author on an abstract accepted for DDW 2003, “Are paper dairies out of date?”
- Co-author: Control Clin Trials 2004; 25: 585 – 97, “Symptom recording in a randomised clinical trial; paper diaries vs electronic or telephone data capture”.
- Several acknowledgements in relation to publications about omeprazole, esomeprazole and budesonide
Special activities in relation to the clinical trials:
With regard to clinical trials with omeprazole and budesonide, I have been involved in several theses.
For the following theses the engagement have been of major grade:
Linda Bardram
Progastrin in pancreas and the Zollinger-Ellison syndrome 1992.
Søren Kruse-Andersen
Extended recording of intraoesophageal pressures and pH 1993.
Lene Hendel
Esophageal and small intestinal manifestations of progressive systemic sclerosis: A clinical and experimental study 1994.
Niels Qvist
Motor activity of the gallbladder and gastrointestinal tract as determinants of enterohepatic circulation. A scintigraphic and manometric study 1995.
Troels Havelund
Management of gastro-oesophageal reflux disease 1996.
Gerda E. Villadsen
Secondary peristalsis and dispensability of the esophagus with particular reference to systemic sclerosis. An impedance planimetric approach 1999.
Claus Aalykke
Aspects of gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs 1999.
Villy Meineche Schmidt
Dyspepsia in primary care and the role of empiric proton pump inhibitor treatment. August 2007.
This thesis includes nine papers based on data from the two clinical trials: The Danish Dyspepsia Project and OPUS.
Ole Kristian Bonderup
Budesonide Treatment of Collagenous Colitis. September 2008
This thesis includes papers based on data from two studies, acute treatment with budesonide and a maintenance trial.
Teambuilding:
Teambuilding Course for Investigators, Medical Dept. M, University Hospital, KAS Glostrup.
The Course was performed in co-operation with Olympeak Coaching, Lars H. Nielsen. The purpose of this special Teambuilding course, was to promote the collaboration between medical departments about clinical research. Idea and design made by Hanne Køhn, Dr. Simon Rune and I. Similar courses have later on been performed at different hospitals in Denmark.
Teambuilding Course of a new concept tailored for Site-teams in relation to the performance of clinical trials. Jeannie Bjerregaard and I designed and performed this at the Medical Department M1, Regional Hospital Randers.
Workshops:
CONWORK, Congress Workshops:
Idea and planning in co-operation with the two Chairmen Dr. Steen Boesby and
Dr. Simon Rune, Medical Dept. AstraZeneca A/S, and the Marketing Dept. GI.
- BSG Meeting in Manchester March 1993, Helicobacter pylori
- OESO, Paris, September 1993, Reflux esophagitis
- DDW, New Orleans, May 1994, Dyspepsia
- DDW, San Diego, May 1995, Inflammatory bowel
- OESO, Paris, September 1996, Reflux esophagitis
- ACG, Chicago, November 1997, Pancreatic diseases and treatment
- MAYO, Hawaii, February 2001, Colorectal Cancer
”How to perform the optimal course for patients participating in a clinical trial”
Head of Department GI, University Hospital Odense, Dr. Karsten Lauritsen together with Anette Larsen, Jeannie Bjerregaard and I at AstraZeneca A/S, did design and perform this workshop. The participants were doctors and nurses from different Hospitals in Denmark.
Danish Esophagus Club:
- Esophagus – 88, March 1988
- Joint Meeting between BSG, Esophageal Section and the Danish Esophagus Club, Birmingham and Rotherham, May Theese meetings were arranged by the two medical societies together with Astra UK, Allison Howe and Astra Denmark, K. Clemmensen-Rotne.
- Esophagus – 94, April 1994 (Member of the Steering Committee)
- Esophagus- 2000
Consultancy
Trial- Support:
- Based on national and international experience from my many years of working with clinical research as well as marketing activities in the medical industry, the Consultancy Trial-Support was established 2008-07-01.
- The objective of Trial-Support is to be a qualified support for the promotion of clinical research, for the healthcare industry and for the best diffusion of scientific knowledge.
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Experience and flexibility
With forty some years of experience from the pharmaceutical industry, Kjeld Clemmensen-Rotne at Trial- Support presents his insights and viewpoints as a consultant with considerable leverage. His company, Trial- Support offers contract research services, and while he collaborates with larger CRO’s in bigger projects requiring several consultants or special deliveries, he generally operates on his own – and with great flexibility on smaller projects, e.g. investigator initiated studies, or other projects that are publically funded that may need support in project management, document handling, trial registration, regulatory issues, monitoring etc. “I have the experience and capacities to contribute at many different levels in a clinical research project, and in principle take part from idea to publication,” Kjeld Clemmensen-Rotne says and carries on, “In particular the practical lead on projects may suffer in publicly funded clinical research, as the focus of hospitals remains the clinical production. This is where I act as project manager providing the link between the investigators and their staff and the health care professionals who are conducting the trial”. Additionally, Trial-Support operates in international set ups: “Being the coordinating national centre in a large scale international research project is prestigious for the hospitals, however also binding. It requires professional handling and strong project management, which is what Trial-Support offers.” In addition to his close collaboration with a couple of specialized CRO’s, Trial-Support also works closely with the Danish GCP Units.asdf
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The following main activities have been or are being performed by Trial-Support:
- AstraZeneca R&D, The Global Nexium Team:
- In relation to the Management Project “24 Hour Challenge”, identifying the status of all clinical trials with Nexium and Losec worldwide, and compiling all information available about data and databases and their availability for inspections and future research (2008-2009)
- CCBR- SYNARC:
- Setting up a core group of General Practitioners in relation to the clinical research performed at the clinic of CCBR-SYNARC in (2009 – 2010)
- GCP Monitor for a phase I trial performed at the clinic of CCBR- SYNARC/C4Pain in Aalborg, testing a drug of a new class from the Spanish Company Estéve (2010)
- Region Sjælland & Region Fehmern Belt:
- Planning, setting up and conducting the international investigator initiated clinical trial SCOT Study (Short Course Oncology Therapy, colorectal cancer) for the Danish sites together with the Country Coordinating Principal Investigator Niels Henrik Holländer, Department of Clinical Oncology & Palliative Units, Zealand University Hospital, Næstved.
- In relation to the SCOT Study a translational part TransSCOT has been sat up too in collaboration with the Country Coordinating Principal Investigator Niels Henrik Holländer, Department of Clinical Oncology & Palliative Units, Zealand University Hospital, Næstved and the Danish Cancer Biobank (DCB).
- With that many patients enrolled in Denmark in the SCOT Trial, all the collected blood- and tissue samples in TransSCOT, together with our well-established infrastructure around Danish Cancer Biobank, we have got two seats in the Sample Access Committee in the UK and one seat in the Biorepository Management Group and thus obtained a great opportunity to be at the leading edge of translational research within the cancer area in the future
- POSICOM:
- Since January 2015 Trial-Support have been supporting the Norwegian Company POSICOM in their effort to get their product Seekuence®Medical , an innovative multimedia system on the Danish market. It’s a program for capturing pictures in relation to treatment of patients, surgical and diagnostic procedures and development of better educations for doctors and trainees. During the last three months of 2015 this equipment was tested at the Zealand University Hospital, Køge in relation to the educational training of five young physicians at the endoscopic department.
- From 2022, Seekuence®Inspection, a similar unique multimedia system for the marine and the maritime areas is to be introduced to the Danish market.