• slidebg3
    sacura gmbh logo


    We worked on more than 70 different indications
    in 25 countries.

    More
  • slidebg6
    sacura gmbh logo


    Sophisticated software solutions for clinical trials

    More
  • slidebg3
    sacura gmbh logo


    Our office at Berlinbiotechpark in Berlin

    More
  • slidebg3
    sacura gmbh logo


    We worked on more than 70 different indications
    in over 25 countries.

    More
  • slidebg3
    sacura gmbh logo


    Biotech's best choice to get your substance ready for the market.

    More

Sacura GmbH

sacura_gmbh_about_1
sacura_gmbh_about_2
sacura_gmbh_about_3

Your clinical trial is the result of many years of development and major investments of your company. To be sure to get the best out of it you need experienced partners, because your clinical study should not be a business trial. Sacura’s team consists of experts in the preparation, set-up, managing and performance of international clinical trials, especially if they are complex and tricky. Sacura is a partner you can rely on concerning agreed milestones and budgets. First of all your study is our mission and a commitment of our engaged staff.

CONSULTING

Meeting requirements of Biotechs in late-stage pre-clinical development planning their first clinical study is our sincere commitment. We understand the individual characteristics of your substance, device and company; we are therefore able to provide special support:

Management consultancy

Management consultancy for clinical development programs for Biotechs, academic institutions and MD companies

State-of-the-art support

Extensive support with a network of veterans previously experienced in leading positions in the big pharma industry

One-stop-shop service

Covering complete life cycle and development process from the Target Product Profile (TPP) to the market access

Crisis management

Continuous risk management, ad-hoc support, problem solution and preventing action. Experienced in the successful management of Rescue Studies.

PROJECT MANAGEMENT

We are acting with flexibility, the experience of more than 130 clinical trials and open communication with you in a joint team to ensure your milestones by managing:

Project planning

Compilation of project management plan and definition of key parameters (milestones, budgets, resources, logistics, project tools)

Project performance

Budgeting and cost management of development projects. Resources management and co-ordination of all third party providers contracted

Quality assurance

Quality is the backbone of a clinical trial. Our systematic approach ensures high-quality data and is the basis of our daily business.

Risk management

A proper risk assessment is used to plan the details of trial management and the approach to and extent of monitoring and controlling the trial

E-COLLABORATION

Sacura implemented in the daily work and study-related processes the web-based collaboration and eTMF system "e.tract" that was developed in cooperation with OrbiTeam Software (Germany), a spin-off of the well-known Fraunhofer Institute for Applied Information Technology, based on their award-winning groupware BSCW.

Document Management

Professional document management with version control that enables involved partners the storage, managing and archiving of all study related documents

Efficient teamwork and communication

Collaboration and communi- cation in a very comfortable and cost saving way regardless of time and location and integrated mobile access

Project control and management

Managing of workflows and coordination of tasks and shared activities of groups and users with role-based access

Data safety and tracebility

The system fulfills all requirements on safety and traceability of any modifications on data and documents including CFR part 11 compliance.

STUDY EXECUTION

We are able to provide the complete study services including:

Selecting & Contracting

Selection and evaluation of key opinion leaders (KOLs).
Coordination of Investigators and suitable study centers including pre-study site assessment.
Budget negotiation, Drawing up and establishment of contracts for study centers and third party providers.

Planning & Implementation

Planning and performing of kick-off meetings.
Implementation of study within the study centers including electronic systems.
Supply of investigational product and non-study drug materials and equipment to the centers.

On-Site Support

Personnel support and site assistance.
Clinical quality assurance, preparation for audits and on-site GCP training.
Support for implementation of the study in the daily work of the site.

Reporting & Submission

Submission/reporting to authorities (Competent Authorities, ECs/IRBs, regional boards, etc.)

Monitoring

On-site Monitoring, Clinical Monitoring, Centralized Monitoring, Data Monitoring

Document Management

Maintenance of TMF/eTMF and ISFs, translation and validation of study documents, providing a central electronic platform for team networking and documentation.

Clinical studies

different indications

different countries

e.tract is a web-based online platform for secure collaboration of all partners in clinical trials. The software simplifies editing, sharing, tracking and archiving of study documents. Central domains of this platform are individually structured workspaces and an electronic Trial Master File - eTMF. All stakeholders get access to their documents and will be supported in study processes. With e.tract you - as a sponsor of a clinical trial - are on the safe side to demonstrate the compliance with the standards of Good Clinical Practice and with all applicable regulatory requirements. The system, which is developed by the companies Sacura and OrbiTeam Software, is based on OrbiTeam's document management and collaboration platform BSCW and used by the big pharmaceutical and small biotech industry.

Learn more

About Us

Sacura is a full-service contract research organization granting a high level of quality (FDA approved), flexible structures and qualified staff. We are dedicated to the success of our clients by providing extensive support through a network of veterans previously experienced in leading positions in the big pharmaceutical industry to cover the entire life cycle process of your product. Working with our partners in a long-term successful partnership oriented cooperation; we are able to serve as a one-stop-shop with the complete spectrum of services for your needs. In the past we have demonstrated that our proven structure and management skills gain a measurable benefit for our clients by completing their development projects earlier. We are experts in the set-up, managing and performance of clinical trials. We love to work in complex, orphan drug studies. We are experienced in more than 70 indications and more than 130 different studies. We were inspected by several authorities including FDA with excellent results – no 483s. Therefore we are able to navigate you through upcoming inspections and to save your rescue study.

abouts_sacura-gmbh_picture-1

Our Mission

... is to complete complex projects successfully, on time and budget. We provide intelligent and innovative solutions, operational excellence and flexibility to guarantee high quality service and transparency.

sacura_gmbh_about_4
sacura_gmbh_about_5
sacura_gmbh_about_6

OUR TEAM

team0

The high level of services we provide is due to our experienced and motivated team – the heart of our organization and the key to our success. We are looking back on more than 20 years of experience in big pharma clinical development, biotech board level resposibility, Contract Research Organizations (CRO) and Site Management Organizations (SMO). Sacura’s employees are active in working groups of the German Society for Good Research Practice (DGGF e.V.) as well as in the BIO Deutschland working group “Regulatory Affairs”. Our staff is regularly trained and covers all aspects of your clinical development programs in the pharmaceutical and medical device sector. A team you wish to work with.

team1

Gabriele Hartwig

Partner and CEO

Gabriele has 26 years of experience in clinical trials, ten of them within the clinical research department at Hoechst AG and 16 in the CRO industry as a managing director.

team3

Dietmar Rescheleit

Partner and Director Business Development

Dietmar is a Biochemist with 20 years of experience in clinical R&D and was in positions including a VP/CSO of a Biotech company and Director Business Development of a pan-European SMO.

team2

Frank Hartwig

Partner and Manager Finance/HR

Frank has 16 years of experience in CRO business in the fields of finance and human resources.

Partners and Memberships

In closely cooperation with our partners we optimize our services and develop new products for our customers. The key personnel of Sacura are engaged in several professional associations and committees.

  • Logo OrbiTeam
  • Logo OrbiTeam
  • Logo Conelis
  • Logo Bio Deutschland
  • Logo DGpharMed
  • Logo DGGF

Contact us

Sacura GmbH

Technologiehof
Mendelstr. 11 | 48149 Münster

Berlinbiotechpark | Bldg. B5.1
Max-Dohrn-Str. 8-10 | 10589 Berlin

Call Us

Phone: +49 (0) 251 98014-90
Fax: +49 (0) 251 98014-91

Phone: +49 (0) 30 3409 64 66
Fax: +49 (0) 30 3409 86 76

GET IN TOUCH