Services

Bali

Our goal is to accelerate and improve the development of Therapeutic, Medical Device and Products.
Get to know more about Sintesi Research and how Sintesi Research support the success of clinical development.

Clinical Operations

Sintesi Research acts as a partner for the whole spectrum of clinical investigations, with ad-hoc teams led by experienced Clinical Project Managers:

  • Interventional Phase I, II, III, IV
  • Retrospective
  • Observational
  • No-profit
  • Medical Device (pre e post market)
  • Nutraceutical

Our services embraces the full path of study, in details:

Study Design

  • Protocol design
  • Feasibility investigation
  • Risk evaluation
  • Clinical development consultancy

Regulatory

  • Medical document preparation
  • IRB/IEC/RA submission
  • Local insurance policies
  • Sites agreement

Project Management

  • Feasibility management
  • Risk Analysis Plan
  • Sites Coordination
  • Monitoring Coordination
  • Proposal of Corrective Actions
  • Check of Study progress
  • Updates to Sponsor
  • Recruitment strategies

On Field Activity

  • Feasibility management
  • Risk Analysis Plan
  • Sites Coordination
  • Monitoring Coordination
  • Proposal of Corrective Actions
  • Check of Study progress
  • Updates to Sponsor
  • Recruitment strategies

Data Management

  • CRF design
  • Database set-up and maintainance
  • RDC Platform
  • Centralized randomization
  • ePRO (Patient diary)
  • Drug & Supply Management.
  • Data cleaning
  • Study metrics
  • Customized report generation
  • Adverse events

Statistic

  • Protocol design
  • Sample size calculation
  • Statistical Analysis Plan
  • Statistical programming
  • Statistical reporting

Medical Writing

  • Clinical documents
  • Papers
  • Study reports
  • Operating manuals

Meetings and Event Organization

  • Investigator meetings
  • Logistic management

Investment

Sintesi Research coordinates private investors working alongside VC  in Medical companies across Europe, Israel and US.

We offer the opportunity to invest in companies at different stages and across all sectors in the Medical area; Drugs, Medical Creams, Medical Device.

Thanks to our extensive experience in managing clinical trials, we have a deep understanding of the industry dynamics and a privileged access to hot deals in the market.

We crave to build a mutually beneficial liaison between investors and entrepreneurs. expertise and connections into some of the most representative in Europe, Israel and US and to turn the VC market competitiveness in opportunities of collaboration to drive value for both companies and investors.

Marketing

Sales, strategic initiatives, business partnerships, market development, business expansion, and marketing are all included in our activities and extend across different departments, including sales, marketing, project management, product management and vendor management, as well as negotiations, partnerships, and cost-savings efforts are also involved. All of these different departments and activities are driven by and aligned to the business development goals of our company.

The business development team assesses further expansion potential. After all due diligence, research and studies, it finds that the product/service can be expanded to different regions.

Our strategy is not just about increasing sales, products and market reach. Decisions are also needed to improve the bottom line, which include cost-cutting measures. An internal assessment revealing high spending on Strategic partnerships needed for these initiatives are a part of business development structure of our company.

Registration Distribution

Our company is well placed to act as a distributor for third-party niche and specialty pharmaceutical products, Medical Device, Food Supplement, Drugs, Cosmetics

Whether you are a non-European, Scandinavian or Latin American Company looking to access these countries, SINTESI RESEARCH is your ideal distribution partner.

Expedite product deployment, Improve product safety and quality Maintain compliance with the following services:

  • Regulatory Affairs
  • Pharma Labeling & Localization
  • QP/Quality Assurance
  • GMP/GDP Auditing

Support your complete product life cycle from launch through maintenance with solutions for the following industries:

  • Pharmaceuticals
  • Medical devices
  • Food supplements
  • Cosmetics