Services

SERVICES

A COMPLETE RANGE

A full range of services one can expect from a medical department.

 

Medical Services :

Support to the sales team, support to the product managers. Create a synergy between the commercial and the medical people.

Clinical Research :

More than ever a complex and articulated process demanding dynamic project management skills

Regulatory Services :

From the submission of a registration file, the pricing and the reimbursement negotiations. Ensure the regulatory maintenance of mature products.

Pharmacovigilance :

Be vigilant. protect the patients, optimize the use of pharmaceutical products, protect... the future of your medicines. Discover the Eudravigilance platform (EVWEB).

 

When would you think about MedicalSigma Consulting pharmaco

  • Need of medical expertise
  • Temporary need of medical/research know how in periods of change
  • You are facing a challenging deadline, you will not hold with the existing staff
  • You are hit by hiring freeze, budget cuts
  • You have some vacant positions due to the difficulty to attract the needed profile within your department
  • You need assistance for your pharmacovigilance obligations

 

MEDICAL SERVICES

MAKING IT FIT

Product positioning : inject the medical input into the marketing strategy. Make the business people aware of the local and international guidelines : e.g. the consensus meetings (FR) - (NL) of the Belgian INAMI/RIZIV, the NICE guidelines, SIGN guidelines, National Cancer Institute (NCI) etc...

Translate the scientific data in business opportunities : we draw the attention of the business people to the most recent informations (published literature, congress presentations, abstracts) to translate them in a promotional message.

Training the business: test our ready-to-use modules regularly updated

  • Disease management in the cardiovascular area (Cholesterol lowering agents, Hypertension and the
  • CNS : depression (based on the CG90 NICE guidance, 2009) and anxiety
  • Infectious disease : See practice guidelines of the Infectious Diseases Society of America (IDSA),
  • BAPCOC guide of antifectious treatment  in Belgium  ( FR & NL only)
  • Digestive diseases
  • Oncology: colorectal cancer
  • Others (list non exhaustive)

    Consistency of the promotional material with the published literature. The founder, Dr Thomson is approved by the Belgian FAMHP (Federal Agency for Medicines and Health Products) for the mandatory revision and approval of the promotional material (Royal Decree April 7, 1995)

    Design of phase IV study. Observational study in line with the marketing strategy

    Literature searches. Identify the most relevant literature published on a particular topic and if needed, preparation of an overview of the significant literature data.

 

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REGULATORY SERVICES

GETTING IT RIGHT

Preparation of Clinical Overview (CTD format).
The Common Technical Document is now the obligatory format for all European, US, Canadian and Swiss registration applications. It is intended to provide a critical analysis of the clinical data in the common technical document (CTD) implemented in July 2003 by the EMEA.

Collection of epidemiological data
How to provide a forecast of the number of patients susceptible to be treated by a new medicine ? We collect not only the published data but also, specifically for Belgium, INAMI/RIZIV and data from the Résumé Clinique Minimum -RCM/Minimale Klinische Gegevens-MKG (Belgium only).

Reimbursement strategy

  • Cost of illness: a preliminary and mandatory step in the pricing and reimbursement process Consider direct and indirect costs. As far as depression is concerned for instance, let's remember that indirect costs are 6 times as great as direct costs. Drug costs account for +/- 10 to 20% of direct costs
  • Benchmarking : compare the evaluation of new medicines by EU countries (e.g. French Transparency Advise), by US FDA ( Guidance documents)
  • Political & scientific lobbying : take benefit of our network

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CLINICAL RESEARCH

KEEP TIMELINES UNDER CONTROL

Keep timelines under control

"I have always found that plans are useless, but planning is indispensable."
(Dwight D Eisenhower)

  • Conception / Evaluation of Clinical Development Plans
    Ensure a reliable scientific content in the clinical development of compounds entering the clinical stage. Write the synopsis of the protocols
  • Evaluation of the feasibility of clinical trials
    most of the existing CRO's will provide outstanding support for the monitoring of your clinical studies. Unfortunately, a careful assessment of the feasibility of the study protocol is often missing. Because it was simply not requested by the sponsor or because the CRO doesn't have the capacity to discuss the protocol from a medical point of view and to document subject's availability in the pre-study phase. Let's stop this inflation of protocol amendments responsible for delays (by repeating regulatory and ethical submissions) and explosion of costs.
  • Writing protocols , case report forms
    we have a library of protocols in many therapeutic areas
  • Investigator's identification, assessment & selection
    this must be closely coupled with the evaluation of the feasibility.
  • Budgeting clinical trials
    Use our templates. Don't reinvent the wheel.
  • Training to study personal on ICH / GCP
    we have a standard training for newly hired study personnel. We have an experience of the organization of trainings for the clinicians and their study staff ( study nurses, etc…)
    • Organization and Planning of clinical studies
    • Patients : Identify patient's population, Recruit and enrol
    • Management of data and documentation, organization of study files "If it is not written, it does not exist."
    • Safety — Adverse events and adverse drug reactions
  • Optimizing the clinical trial processes
    A day of delay in the development of new compounds means a lose of between $300,000 and $ 2 or 3 million depending on the sales forecast. In the facts, it's not surprising that most of the registration trials will last 30 %-45% longer than expected.
  • Developing "clinical metrics" to quantify the performance of the clinical staff. Identify, select and implement key performance indicators as an evaluation tool for your clinical staff. Set clear standards at each step of the process; ultimately, implement these standards in the yearly performance review in collaboration with your Human Resources Manager. See examples here below.
    • How many days between a final protocol and a start-up visit ?
    • How many days between First Subject In (FSI) and Last Subject In (LSI) ?
    • How many sites visits are you expecting from your monitor.
  • Managing a clinical project
    even when you outsource a complete project, you will need to have this interface with the CRO.

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PHARMACOVIGILANCE

SAFETY FIRST

Pharmacovigilance looks like a scarecrow for many companies !

Fulfilling your regulatory obligations require different skills: interpreting the medical data provided by the reporter, collecting additional data in most of the cases, adequate coding, writing a comprehensive narrative. Knowing the regulations in terms of reporting (in accordance with the Notice to Marketing Authorisation Holders issued by the European Medicines Agency (EMA) and the specific requests of the different European Agencies.

The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislationGVP modules I to XVI cover major PV processes and the development of this set of guidance is concluded.

 

The practical implementation of the Good Pharmacovigilance Practices (GVP) is a real challenge especially for the small pharmaceutical companies in terms of manpower and processes. Not only, it supposes a complete revision of the Standard Operating Procedures but it starts with the creation of the Pharmacovigilance System Master File replacing the DDPS. Hereafter some of the requirements, the list is not exhaustive bu gives a first idea of the related workload

TIP: Just type "EMA GVP" on your favourite search engine to have access to the latest GVP modules

  • Appoint a Qualified Person for Pharmacovigilance (QPPV) AND a Deputy QPPV
  • Have a complete set of Standard Operating Procedures
  • Organize regular training for the Sales Force and for the Administrative personnel in-house (See footnote)
  • Specific training for the people in charge of the PV
  • Monitor the scientific literature locally and globally. The Medical LiteratuMonitoring (MLM) service recently launched by the agency requires a revision of your SOP
  • Be prepared for an audit of your authorities. MedicalSigma recently assisted a medium size company to implement corrective actions after a audit. A valuable training tool !
  • Report adverse events electronically via Eudravigilance and keep adequate filing records
  • Signal Management and Risk Management Systems
  • Prepare and submit Periodic Safety Update Reports (PSURs) to the national competent authorities
  • Prepare a Risk Management Plan (See EMA guidelines)
  • For the companies performing clinical studies, prepare and submit a Development Safety Update Report (DSUR) annually for the ongoing clinical trials (See Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use).

 

What is the solution for the Small and Medium Size companies?  EVWEB on Eudravigilance

EVWEB is specifically designed for Small and Medium Size Enterprises (SMEs), which do not have a fully ICH E2B (R2) compliant pharmacovigilance system . It provides the tool (including a version of the MedDRA dictionary)  to allow SMEs secure electronic reporting to the EMEA and all Competent Authorities in the EEA. EVWEB allows the sending and receiving of safety and acknowledgement messages in compliance with the latest ICH M2 standards.
It also allows the saving of all messages at the local computer as well as the  standardization of message senders and receivers registered with the EMA as part of the EudraVigilance community.
Practically, MedicalSigma was recently certified by Eudravigilance. Your company can be registered in the Eudravigilance database (as MAH or study sponsor) and we can act as third party provider to fulfill your regulatory obligations. 

 

(*): We have to recognize that the implementation of an effective pharmacovigilance in a marketing organization can be very challenging: only an integrated marketing-medical-regulatory concept with a focus on the customer can generate adherence of the different stakeholders. From a marketing point of view, it must be regarded as an customer support service  ! 

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