Therapeutic Expertise

Cardiology - CRM and EP

D-TARGET has a long tradition in cardiovascular research for medical devices. We have supported the approval of many new devices including ablation systems, CRT devices, transcatheter valves, drug eluting stents, catheters and cardiac assist devices.

D-TARGET has managed 27 cardiology medical device studies treating approximately 22,000 patients within the past three years.
In CRM / Ablation therapy indication we suppported 7 projects treating more then 1700 patients.  We have also provided either standalone or consulting services for an additional 11 cardiology projects including Atrial Fibrillation or Cardiac Rhythm Management devices.

Recently, D-TARGET successfully completed the First in Man/CE Mark trial of an innovative ablation catheter. As a result of our performance on the first trial, D-TARGET is currently running an FDA IDE study in the US and Europe for the same sponsor and device.

In addition, we are currently supporting three post marketing trials (two with scientific approach, one European registry) and one pilot trial in Atrial Fibrillation/Cardiac rhythm management. These studies are currently being managed in the following countries: US, Germany, Czech Republic, Netherlands, France, Monaco, Switzerland and the United Kingdom.

 

KOL Network

D-TARGET is currently working with notable sites and key opinion leaders in Europe and the US.


Europe:
Leiden, Zwolle, Rotterdam, Leuven, Brussels,  Geneva, Bern, Basel, Thun, Fribourg,  Leipzig, Bad Nauheim, Dresden, Berlin, Munich, Bad Segeberg, Hamburg, Bad Krozingen, Munich, Bad Oyenhausen,  Coburg, Vienna, Graz, Prague, Warsaw,  Monaco, London, Leicester, Manchester, Milano,Lugano, Rome, Madrid, Barcelona, Stockholm, Malmö, Kopenhagen, Oslo,  Rennes, Paris, Nantes, Toulouse and Bordeaux - to just name a few.


US:
Boston, Philadelphia, New York, Austin, Columbus, Chicago, Oklahoma City, Cleveland, Birmingham, Charleston, Rochester, Ann Arbor, Charlottesville, San Francisco, Fresno, San Diego, Cincinnati, Denver, Los Angeles, Plano, New Haven

 

Cardiology (CRM & EP) Study Experience within past three years

Indication

Phase

Sites

Subjects

Services

Region

Arrhythmias

 

 

 

 

 

Atrial Fibrillation

(Ablation Catheter)

Pivotal/ IDE

18

300

Full Service

US, Europe

Atrial Fibrillation

(Ablation Catheter)

Registry

20

300

Full Service

Europe

Atrial Fibrillation

(Ablation Catheter)

Pilot / CE

8

100

Full service

Europe

Ablation Catheter

Pilot / CE

6

60

CM, PM, Safety, SUM

Europe

Atrial Fibrillation

(Ablation Catheter)

PMS

3

100

CM, PM, Safety

Europe

Cardiac Rhythm Management

Pilot

10

100

Full Service

Europe

Cardiac Rhythm Management

PMS

20

800

CM, PM

Europe, Australia, Israel

Standalone/ Consulting Projects

Service

Region

Arrhythmias

 

 

Data Management Support for Ablation Catheter used in the Treatment of Cardiac Arrhythmia

BM

Europe

Medical Writing and Regulatory Support for Ablation Catheter used in the Treatment of Cardiac Arrhythmia

MW, RA

Europe

Medical Writing and Regulatory Support for Cardiac Assist Products used in

the Treatment of Cardiac Arrhythmia

MW, RA

Europe

Regulatory Strategy, Quality assurance, Strategic Product Development for Atrial Fibrillation Device

QA, RA

Europe

Regulatory Support/CE Marking for Ablation Catheter used in the Treatment

of Cardiac Arrhythmia

RA

Europe

 

 

 

Services

BM

Biometrics ( Data Management, Statistics, CRF, IVRS )

PM

Project management

CM

Clinical Monitoring

FS

Functional Sourcing

RA

Regulatory affairs

SUM

Submissions management

QA

Quality assurance

MW

Medical writing