Knowledge-based Studies for fast-track Market Entry

Your innovative product is to help the patients of tomorrow? You are looking for the motivated and promising study centre? You can’t leave the success of your clinical trial phase I to III to chance?

MEDIACC, the independent institute for Medico-Academic Consultings, provides made-to-measure services to their clients based on 20 years scientific experience – on demand. We operate internationally based in Germany.

Successful translation of innovative diagnostics and therapies in marketable products strongly depends on their proven benefit the patient. Clinical trials are crucial for transfer of research into patient care. They are a powerful motor for innovation in health research and health care system. Thus, they form the basis for evidence-based medicine and ensure optimum quality of medical care.

From the Idea to the Innovation. MEDIACC.

Healthcare decision makers and health insurers increasingly weigh up costs and benefits of innovative therapies and diagnostics. Their decision determines acceptance in service and fee catalogues and remuneration. High quality of your studies determines broad acceptance – MEDIACC actively supports you. We offer knowledge-intensive services to the core strength of cutting-edge technologies in research-oriented enterprises, with the express purpose of leveraging synergies.

Whenever and as long as you need it:

  • no time-consuming personnel recruitment,
  • on the latest scientific knowledge,
  • no costly training time.

MEDIACC understands the Needs of Start-Ups.

Especially young Start-Ups benefit from an initial potential analysis and the subsequent development of a realisation plan including a structured development plan.

The potential analysis consists of:

  • Medical and scientific consulting
  • Competitor analysis
  • Prospects on the 1st or 2nd healthcare-market, Estimation of the costs needed for entering the subsequent markets; Timescale for the market-entry of the relevant markets, taking current guidelines and the current state of knowledge as well as currently running national and international studies into account.
  • Statistical calculation of the number of subjects.
  • Consulting on legal, regulatory and ethical requirements and their implications on the potential product.
  • Time- and budget-planning of a GCP compliant clinical trial.
  • Development of marketing strategies as well as influencing the user-acceptance within the healthcare-market.
  • Healtheconomic calculations.
  • Choice of suitable public funding programs.
  • Estimation of the costs for the development of an authority-compliant motion for a clinical trial and the resulting market-segments, respectively the lifecycle-curve as well as the time to market-entry
  • Criteria for the reimbursement by health-insurance companies (additional benefit to the current guideline-compliant therapy)

Subsequently a structured development plan will be set up to note down the identified risks of the project and to development an authoriy-compliant motion for the clinical trial.

MEDIACC for the Success of Your Idea to Worldwide Approval

The bases for this are scientifically-founded studies, consequent implementation throughout the trial with attention to details. MEDIACC has in-depth knowledge from many years experience from research, academic work and clinical practice. In addition to specialist skill and a professional approach, our clients value our neutrality, speed in the processes and confidentiality. Finding unusual solutions customised to the needs and benefit of our customers are our objectives. Our success rests on the high level of satisfaction of our customers.

Your benefits:

Our Senior Project Leaders and Senior Scientific Advisors consult and support you as clients from research, pharmaceutical and biotechnological companies. We are particularly committed to the concerns of small and emerging enterprises.

From

  • The initial idea
  • Scientific publications
  • Patent- or product development
To
  • Effective public presentations.

As your Partner, we from MEDIACC offer tailor-made Solutions or Complete Packages:

Project management

  • Conception, design and conduct of preclinical, translational and clinical studies,
  • Medical expertise and training (esp. Internal Medicine, Cardiology, Innovative Medicine and Therapies),
  • Identification, selection and recruitment of clinical trial centres or collaborating laboratories,
  • Compilation or assistance with examination records, study documents (protocol, CRF, patient consent form, investigator file, SOP for study centres),
  • Preparation and review of data management bank and safety data (including, adverse events (AE), serious adverse reactions (SAE), laboratory data, vital signs, medical history, physical examination, concomitant medication, treatment workflows),
  • Regulatory support and communication with German regulatory authorities (BfArM, DIMDI, Ethikkommission, PEI),
  • Review of coding and validation of adverse reactions, concomitant medications for accuracy and consistency, clinical trial management,
  • Coding and evaluation of adverse effect, concomitant medication and serious adverse effects regarding accuracy and consistency,
  • Development of time schedules, budget and operating plans
  • Assistance with applications for public funding.

Monitoring

  • Assistance with the conduct of your trial in accordance with ICH-GCP,
  • Support with a monitoring team in line with existing standards and regulations; visit during the selection phase, initiation and during the study.

Biometrics

  • Biometric consulting, calculation of power and sample size,
  • Statistical evaluation according to the analysis plan, midterm and final statistical evaluation.

Medical Writing

  • Documentation of study process and detailed illustration of the results according to ICH-E3, DIN EN ISO 14155,
  • Interpretation of data,
  • Publication of results the most high-ranking in scientific or clinical journal possible.

Additional Services

  • Continuous medical and scientific advice and expertise to your staff, interfacing with clients and external medical experts,
  • Specialist consultancy and support at in-house or external conferences, or investigator meetings,
  • Professional development and delivery of scientific and medical presentations of materials to sponsors / clients / bodies and authorities,
  • Expert assistance with effective public presentations and marketing activities,
  • Assistance with selection of suitable support programs and funding.

Our services use approved and continually updated Standard Operating Procedures (SOP). We are utmost committed to keep your project within defined contents, budget and time constraints.

Our core Competences for the Fast-track of Your Products.

As our clients, you profit from our network of university and extra-university research establishments in the region, as well as international partners. The latest legislations and European directives and regulations are implemented, including international standards (recommendations of World Medical Association (WMA) in the Declaration of Helsinki, guidelines of ICH-GCP (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human use – Guideline for Good Clinical Practice, guidelines of the European Union (EU), guidelines of the Food and Drug Administration (FDA), CONSORT-Statement, STARD, SAMPL, DIN EN ISO 14155, DIN EN ISO 9001). Expect us to be on the very latest knowledge for your studies.

Our strength lies in efficiency, independence and reliability in the implementation of our customers‘ ideas and visions into successful studies and trials – for expediting time-to-market and peak-market presence. Complete your competences through external specialists.

Shorten the Process Times with MEDIACC.

© 2018 MEDIACC GmbH