Cancer Consultants have consultants who are experts in the development of cancer-fighting drugs. Their area of experience includes the design and development of clinical trials, consultation and strategic evaluation for oncological pharmaceutical companies and analysis and evaluation of of the pharmacokinetic and pharmacodynamic profile of oncological drugs in clinical and pre-clinical studies.

To be more specific, the drug development advisory services offered by Cancer Consultants are:

1. Design of clinical investigations phases I to III (protocol, informed consent) and pharmacokinetic investigations (pre-clinical and clinical, phase I, population analysis, bioequivalence research, food effect research)
2. Specific training of the team members for a project
3. Training of data managers
4. Design of data tables which optimise later analysis of the data
5. Evaluation of the clinical data of an investigation
6. Pharmacokinetic analysis (compartmental, non compartmental, population) and pharmacodynamic analysis of the data generated during an investigation
7. Revisión de todos los documentos relacionados con el estudio (informes del estudio clínico, manuscritos, abstracts, presentaciones, sumisiones a agencias regulatorias).
8. Decisiones “go/no go” en estudios fase I y II.
9. Representación de clientes en reuniones con agencias regulatorias, si es necesario.

 

SPECIALITY AREAS

Cancer Consultants, via their team of senior consultants, occasionally backed up by independent consultants who specialise in specific areas, offer a general consultancy service to the pharmaceutical industry, including the different areas of specialisation.

Strategic evaluation of cancer drugs

Cancer Consultants give their strategic perspective to the Industry on cancer drugs, both those that are similar to established drugs and new compounds aimed at molecular targets. By reviewing the existing preclinical and clinical data on a particular drug, we evaluate its potential in Oncology, both in absolute terms and in comparison with other candidate drugs, in the context of an in-depth, up-to-date knowledge of cancer medication and the dynamic and changing models of cancer therapies. Our exhaustive evaluation of the existing pharmacological, toxicological, clinical and regulatory data, in the context of its possible practical day-to-day significance in a clinical application, gives the sponsor a different, specialised vision, with strong emphasis on the pragmatic, of their products, with their weak and strong points, in order for them to establish the necessary strategies.

Pharmacokinetic and pharmacodynamic research

We design and supervise pharmacokinetic and pharmacodynamic preclinical and clinical research, ensuring that the PK/PD information obtained is correctly focused and complete. In this way, we get research which is more informative, something which is essential for the acceleration and optimisation of the drug development process. We also analyse the pharmacokinetic and PK/PD conventional and population research data with specific software (WinNonLin, NONMEN), both of individual agents and in combination.

Clinical development programmes

Cancer Consultants collaborate in recommending treatment schemes and regimes for Phase I trials, based on preclinical findings, action mode, dose-response curve, scheme dependency, resistance mechanisms and pharmacokinetic and pharmacodynamic data. We also help to select suitable groups for the development of phase II and III investigations, with a clear focus on marketing strategies, taking into account both the profile of the drug to be studied and the analysis of development programmes for similar drugs, both failed and successful, as well as retrospective reviews of data and clinical research that may suggest alternative forms or different focuses for the development of the product. In some cases, we also help to define the existence of "niche" groups where some new drugs and drugs that are already known, but under-used, could cover orphan oncological indications of efficient treatments, both as sole agents or in combination.

Post-research services

Once Phase III trials have been completed, Cancer Consultants can offer the Industry a variety of post-trial services. These include preparing clinical summaries and reviews for the regulatory agencies, writing publications and abstracts for scientific journals and international conferences, presenting data at scientific fora, and training sales personnel.

Price: varies, according to the service requested.
Request: info@cancer-consultants.com

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