Our Services

Throughout clinical project management we closely monitor all steps, safeguard the high level of quality and ensure compliance with EU and local legislative requirements.

In order to encourage a corporate culture where clinical research can thrive, it is important to take the time to understand an organization’s research strategy, structure and systems.

Synovia has the innovative and in-depth knowledge to assist and support you throughout phase III and phase IV clinical projects, including :

• Consultation during all phases of a clinical project

• Clinical trial design and project development

• Preparation  of study documentation

• Data management

• Statistical analysis

• Final report writing

• Publication plan development; publication preparation and submission

We provide the following services:

• Medical  writing

  – Medical overviews & trend analysis

  – Publication writing and publication plan development

  – Expert clinical reports

  – Medical promotional support (Product and Disease Information)

  – Regulatory documentation preparation

• Training Manuals

• Preparation of presentations, articles, and other materials  for international conferences, workshops, symposia, drug launches and  trainings (educational, promotional, scientific)

• Disease awareness campaigns – public oriented health activities

• Building of a worldwide  key opinion leader network

We can help you with:

• Development and support of branding and image projects

• Trademark development and protection coordination

• Launch support and organization

• Promotional campaigns and material development

• Marketing plan development

• Event management (conferences, symposia, internal events from idea to realization)

• Marketing Education

A profitable business comes from great ideas – Synovia develops and implements them for you.

Synovia sets up a strategy and trains your staff for the maximum benefit of the company. Just as  Antoine de Saint-Exupery’s would say:  If you want to build a ship, don’t drum up the men to gather wood, divide the work and give orders. Instead, teach them to yearn for the vast and endless sea. (“The Wisdom of the Sands”)

We can provide following education and trainings :

• Biostatistics

• Project management

• Marketing educations

• Medical educations

• Different therapeutic areas and conditions trainings

and we can help you in organization of professional events, meetings and educational courses .

 Through synergy and innovation Synovia brings you the right solutions. 

Synovia fulfills and consolidates regulatory requirements as well as company expectations by providing:

• Infrastructure and Databases

• Individual Case Safety Report (ICSR) processing

• Expedited reporting, including Eudravigilance

• Clinical trial SAE / SUSAR management

• Periodic reporting, including ASRs and PSURs

• Literature screening and review

• Qualified Person for Pharmacovigilance (QPPV)

• Detailed Descriptions of PV Systems (DDPS)

• Risk Management Plans (RMP)

• Training

• Safety Data Exchange Agreements

• Signal Detection and evaluation; advice on safety issues

• Responding to inquiries from Authorities

• Identifying and communicating changes to Risk / Benefit

Synovia offers you knowledge, skills, tools and techniques for any given or possible project activity in order for you to meet or exceed your needs and expectations.  We will make sure that each stage of your project is managed with the utmost professionalism.

At Synovia we have accumulated vast experience running various corporate projects. This was recognized by BMC, an elite international management consulting firm specializing in Global Project Management training and consulting. We are a BMC* partner for South Eastern Europe countries for project management consultancy and training.

link: http://www.bmc-online.com/Home.aspx