What we do

What we do

We would like to become the preferred partner of our costumers, characterized by a higher level of flexibility, offering strategic consultancy and operational execution of the clinical trials they need at a lower cost than full service CROs would be able to do, with at least the same quality and within at least the same timelines. The cost reductions is achieved through an increase in efficiency and effectiveness and this is done by some of the service parameters outlined below.

It is the fully integrated medical-marketing service which drives the difference, right from the beginning of the earliest stages of clinical development up to late stage of life cycle management.

The services we are offering includes, but are not limited, to:

Medical-Scientific Strategic Consultancy Services
  1. Indication analysis
  2. Early and full Clinical development plans with Go/No-Go consultation for clinical studies
  3. Medical Affairs and Strategy Plans
  4. Medical Writing
    • Clinical study report
    • Manuscripts,
    • Presentations,
    • Data analysis,
    • Literature surveys,
    • Statistics reports
Strategic Marketing & Financial Management Services
  • Value chain and life cycle analyses for product development in key healthcare markets – US, Japan & EU
  • Strategic re-evaluation and profitability through Porter’s Five Forces, McKinsey’s 7Ss, BCG Analysis, Strategic Clocking and other in-house frameworks
  • Healthcare branding & communication strategies – In-house use of brand audits and brand leadership equity models to maximize the ROI of your advertising spend
  • Product and R&D investment appraisal in terms of key financial ratios and market indicators
  • Branding
  • Life-cycle Management
Operational Medical Services
Medical & Scientific Lead for planning of Clinical Trials (Phases I-IV) covered by partnering CROs including:
  • Study planning and document preparation (including protocol and investigator brochure development, GCP/SOP preparation)
  • Outsourcing selection
  • Study feasibility and site selection
  • Project Management
  • Regulatory activities and Ethics submissions
  • Pharmacovigilance
  • Data Management
  • Development or selection of electronic data capture system (eCRF), validation and management
  • Development or selection of other electronic study tools
  • Medical Records & Patient Safety assessment and implementation of electronic system
  • Selection of any other vendor needed for the conduct of the trial, including certification and management
  • Training of study team
Operational activities within Medical Affairs
  • Network development and knowledge expansion
  • Development and management of external experts
  • Review of medical documentation used by marketing and sales forces
  • Execution of Post-Marketing studies for life cycle management
  • Post-Marketing pharmacovigilance service
  • Evaluation of investigator sponsored trial proposals for funding
Regulatory Liaison Services​
  • Data collation and market research in key healthcare markets – PanAm, EU & APAC regions
  • Supporting due diligence meetings with pharmaceutical companies
  • Regulatory consultation/negotiation with key government bodies
  • Strategic tie ups with in-country caretakers
 
 
Operational Marketing Services
  • PRINCE2 implementation for ICT design and development of healthcare systems
  • “Make or Buy” decisions, job, batch and flow-line process dependency of facility layout, queuing techniques and matching output to demand
  • Inventory control and chain management issues
Additional Services
  • Clinical Development Funding
  • Corporate Development and Repositioning

Therapeutic expertise

We support you in the clinical development, medical affairs and marketing of small molecules (including generics), biologics (including biosimilars), phytotherapy (including cannabinoids) and medical devices.  

In addition to our own long lasting experience we can build our therapeutic expertise on a network of preselected therapeutic advisors.

We work on all indications in the following therapeutic areas:

  • Neurology
  • Psychiatry
  • Sleep Medicine
  • Pain
  • Oncology
  • Rare diseases