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Consulting services Print E-mail

The services offered by EL Medical Consulting fall into 3 categories

  • Multidisciplinary support to biotech management
  • Scientific support to investors
  • Medical expert role for life-science companies

Multidisciplinary support to biotech management

As part of a life-science development consultancy network, EL Medical Consulting offers multidisciplinary support to biotech management.

  • Preparation of drug development plans taking off set in the Target Product Profile and including pre-clinical, clinical and regulatory perspective
  • Due diligence services
  • Preparation of business plan for a company
  • Preparation of a business case for a product or a group of products
  • Preparation of and participation at meetings with regulatory agencies on behalf of the Sponsor
  • Writing of orphan drug applications

Scientific support to investors

Selection of biotech assets is associated with a high risk of investment failure and financial loss. Informed decision making, based on asset-specific likelihood of success can reduce the risk of investment failure and increase the success rate of the investment portfolio.

EL Medical Consulting has developed a method for assessing the likelihood of success of biotech assets entering a given phase of clinical development. The method takes into account the therapeutic area-specific success rates and the expert evaluation of key success factors based on the available data on the compound and its intended therapeutic use. The method permits comparison of estimated likelihood of success between different assets. It can also be used for calculation of asset-specific risk adjusted Net Present Value.

Medical expert role (on interim contract basis or ad-hoc):

  • Compiling of Investigator’s Brochures
  • Clinical Trial design, synopses and protocols, including statistical contribution
  • Medical monitoring and data consistency checks
  • Interpretation, presentation and publication of clinical data
  • Preparation of site eligibility questionnaires
  • Visits to investigational sites to enhance recruitment and protocol compliance
  • Establishing Data Monitoring Boards, Scientific Steering/Advisory Committees and Adjudication Committees for clinical trials
  • Preparation of clinical study reports
  • Preparation of clinical content of briefing packages, submission dossiers and presentations for regulatory agencies
  • Therapeutic area training of company staff
  • Generating proposals for line-extensions and new indications
  • Analysis of unmet needs for therapeutics and review of competitors
  • Physician -interview based market surveys
  • Preparation of Target Product Profile and validation through KOL interviews
  • Medical writing
  • Medical evaluation of in-licensing proposals
  • Clinical due diligence

Therapeutic areas

We have worked with a range of therapeutic areas including CNS (stroke, Alzheimer's, Parkinson’s, brain tumours, MS, pain), haemostasis & haematology (deep vein thrombosis/pulmonary embolism, haemodialysis, immune thrombocytopenia, prevention of RhD isoimmunisation, disseminated intravascular coagulation, iron deficiency anaemia, antithrombin deficiency), atherosclerosis and women’s health. Other areas include colitis, infectious diseases, ARDS and angina.

Our medical and drug development skills apply in general to any therapeutic areas.