Clinical Research

Based on the ICH GCP guideline, in order to ensure the safety and quality of the medical device in humans, clinical tests need to be performed in accordance with the DIN EN ISO 14155. …

We assist you with all types of clinical trials in processes from:

  • Input and support for the clinical study design
  • Clinical trial planning
  • Evaluation of the clinical trial protocol and the Case Report Form (CRF)
  • Evaluation of the Patient Information Sheet and Informed Consent Form (PIS/ICF)
  • Creation of the Trial Master File (TMF) and Investigator Site File (ISF)
  • Preparation of essential study documents
  • Contract Management
  • Preparation and conducting of clinical trials, timeline and budget implementation

Clinical Affairs

Clinical Affairs oversees all clinical strategy and operations supporting product development and commercialization objectives. …

This includes set up and support for the design and successful execution of clinical studies under adherence to GCP and other regulatory requirements. Soluta Consult offers you the following services to support and advise you for the clinical strategy:

  • Management of process for qualifying, selecting and contracting of clinical study related vendors – Medical Science Liaison Management
  • Accountability for timely communication of project status
  • Support of FDA communication as well as coordination of Key Opinion Leaders
  • Analysis of effectiveness of clinical processes and their alignment with rules and regulations in key global markets
  • Post-market surveillance
  • Support in building a systematic KOL/OL management, Frequent User Support Systematic literature research in the context of clinical evaluations and preparation of technical documentation
  • Consultation for internal and external examinations, application observation of medical devices considering the product life cycle
  • Systematic literature research in the context of clinical evaluations and preparation of technical documentation

Project Management

We provide you with complete presentations of your clinical data according to the clinical trials results for further translation into claims and market related demands. …

We provide and support you with in the following activities:

  • Development of a project plan and planning of the entire milestone map
  • Evaluation of the clinical trial protocol
  • Identification and selection of clinical study sites
  • Budget planning
  • Contracts and subcontracts with involved clinical study sites
  • Compliance Control
  • Coordination of the monitoring
  • Organization of investigator meetings and study meetings
  • Preparation of final clinical study report

Monitoring

The monitoring represents a continuous quality control. It serves to protect the rights and well-being of the study participants. …

Clinical monitoring ensures and documents adherence to the clinical trial protocol within the scope of legal requirements in clinical trials. We have experienced Clinical Research Associates (CRA) on site, specialized in medical devices for conducting your study with the highest quality. The monitoring of your on-site clinical trial in the clinical study sites is planned in consultation with you.

We offer you the following main activities:

  • Preparation and conducting of the Clinical Trial → Evaluate – Initiate – Monitoring – Close-out
  • Source Data Verification (eCRF/Paper CRF)
  • Instruction of clinical study sites in the eCRF system
  • Query management
  • Creation of essential documents and archiving
  • Preparation for Audits and Inspections
  • Completion of CAPAs (corrective and preventive actions)

Quality Management

The standards DIN EN ISO 9001 and DIN EN ISO 13485 form the basis for an effective quality management system for medical device manufacturers. …

The continuous maintenance and improvement of the company quality management system are essential requirements.

We provide you with the following services:

  • Creation of Standard Operation Procedures (SOPs) in the field of clinical research
  • Support during audits and inspections at participating clinical study sites

Regulatory Affairs

The ever-increasing regulatory and policy requirements are a major challenge for medical device manufacturers. …

We support you in fulfilling these requirements and offer you the following services in the field of Regulatory Affairs:

  • Preparation of application documents for submission to the Ethics Committees and Regulatory Authorities
  • Application for approval by the Ethics Committees and Regulatory Authorities
  • Control of adherence to the timelines
  • Submission of final clinical study report
  • Obtaining essential study documents for the submission from participating clinical study sites
  • Evaluation of subsequent amendments (Amendments)

Clinical Research

We provide you with complete presentations of your clinical data according to the clinical trials results for further translation into claims and market related demands.

We provide and support you with in the following activities:

  • Development of a project plan and planning of the entire milestone map
  • Evaluation of the clinical trial protocol
  • Identification and selection of clinical study sites
  • Budget planning
  • Contracts and subcontracts with involved clinical study sites
  • Compliance Control
  • Coordination of the monitoring
  • Organization of investigator meetings and study meetings
  • Preparation of final clinical study report

Clinical Affairs

Clinical Affairs oversees all clinical strategy and operations supporting product development and commercialization objectives.

This includes set up and support for the design and successful execution of clinical studies under adherence to GCP and other regulatory requirements. Soluta Consult offers you the following services to support and advise you for the clinical strategy:

  • Management of process for qualifying, selecting and contracting of clinical study related vendors – Medical Science Liaison Management
  • Accountability for timely communication of project status
  • Support of FDA communication as well as coordination of Key Opinion Leaders
  • Analysis of effectiveness of clinical processes and their alignment with rules and regulations in key global markets
  • Post-market surveillance
  • Support in building a systematic KOL/OL management, Frequent User Support Systematic literature research in the context of clinical evaluations and preparation of technical documentation
  • Consultation for internal and external examinations, application observation of medical devices considering the product life cycle
  • Systematic literature research in the context of clinical evaluations and preparation of technical documentation

Project Management

We provide you with complete presentations of your clinical data according to the clinical trials results for further translation into claims and market related demands.

We provide and support you with in the following activities:

  • Development of a project plan and planning of the entire milestone map
  • Evaluation of the clinical trial protocol
  • Identification and selection of clinical study sites
  • Budget planning
  • Contracts and subcontracts with involved clinical study sites
  • Compliance Control
  • Coordination of the monitoring
  • Organization of investigator meetings and study meetings
  • Preparation of final clinical study report

Monitoring

The monitoring represents a continuous quality control. It serves to protect the rights and well-being of the study participants. Clinical monitoring ensures and documents adherence to the clinical trial protocol within the scope of legal requirements in clinical trials. We have experienced Clinical Research Associates (CRA) on site, specialized in medical devices for conducting your study with the highest quality. The monitoring of your on-site clinical trial in the clinical study sites is planned in consultation with you.

We offer you the following main activities:

  • Preparation and conducting of the Clinical Trial → Evaluate – Initiate – Monitoring – Close-out
  • Source Data Verification (eCRF/Paper CRF)
  • Instruction of clinical study sites in the eCRF system
  • Query management
  • Creation of essential documents and archiving
  • Preparation for Audits and Inspections
  • Completion of CAPAs (corrective and preventive actions)

Quality Management

The standards DIN EN ISO 9001 and DIN EN ISO 13485 form the basis for an effective quality management system for medical device manufacturers. The continuous maintenance and improvement of the company quality management system are essential requirements.

We provide you with the following services:

  • Creation of Standard Operation Procedures (SOPs) in the field of clinical research
  • Support during audits and inspections at participating clinical study sites

Regulatory Affairs

The ever-increasing regulatory and policy requirements are a major challenge for medical device manufacturers.

We support you in fulfilling these requirements and offer you the following services in the field of Regulatory Affairs:

  • Preparation of application documents for submission to the Ethics Committees and Regulatory Authorities
  • Application for approval by the Ethics Committees and Regulatory Authorities
  • Control of adherence to the timelines
  • Submission of final clinical study report
  • Obtaining essential study documents for the submission from participating clinical study sites
  • Evaluation of subsequent amendments (Amendments)

MISSION STATEMENT

Initiate.
Monitor.
Results.

Initiate. Monitor. Results.

As a united competence group of scientists, medics and legal counsels, we work with you to address your clinical research questions as well as plan and conduct clinical trials for your innovations in medical devices.

For us, quality, transparency and effectiveness are the top priority for a successful cooperation with you.

Soluta Consult is a service company founded by Dr. Dana Adyani-Fard, Agnes Anna Kamp and Jelena Simona Klein. We are professionals with a profound working experience in the field of clinical research within the medical device and drug act.

We aim to provide you with a competent and solution-oriented clinical research consulting for your medical devices with the benefit of a multidisciplinary approach. We are a qualified, interdisciplinary team and offer a wide range of clinical research services for innovative medical device manufacturers. We are particularly distinguished by our profound and professional experience in the field of medical devices regulation.

We advise, plan and realize your clinical studies from initiation, monitoring up to close out. With a substantial and longstanding expertise, we meet the growing requirements for the targeted clinical translation of your medical devices in accordance to the legal regulations of the medical device act.

We are always inspired by the latest research results and continue to train ourselves in various disciplines.

ABOUT US

ABOUT US

Soluta Consult is a service company founded by Dr. Dana Adyani-Fard, Agnes Anna Kamp and Jelena Simona Klein. We are professionals with a profound working experience in the field of clinical research within the medical device and drug act.

We aim to provide you with a competent and solution-oriented clinical research consulting for your medical devices with the benefit of a multidisciplinary approach. We are a qualified, interdisciplinary team and offer a wide range of clinical research services for innovative medical device manufacturers. We are particularly distinguished by our profound and professional experience in the field of medical devices regulation.

We advise, plan and realize your clinical studies from initiation, monitoring up to close out. With a substantial and longstanding expertise, we meet the growing requirements for the targeted clinical translation of your medical devices in accordance to the legal regulations of the medical device act.

We are always inspired by the latest research results and continue to train ourselves in various disciplines.

CONTACT

Management:
Dr. Dana Adyani-Fard
Agnes Anna Kamp
Jelena Simona Klein

Soluta Consult GmbH i. Gr.
Mergenthalerallee 10-12
D-65760 Eschborn
Phone +49 6196 58655-545
Fax +49 6196 58655-500
info@soluta.eu

Please contact us