Clinical Research

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Introduction

Poseidon CRO offers phase II-IV trial management, as well as all classes of medical device investigations, from single-center to multi-national projects. With more than 10 years experience of working with majority of indications and products, our competent, dedicated and flexible study teams are ready and able to deliver.
We manage projects from start to finish, but are also happy to work as an integrated part of your own study team.
The dedicated and professional Poseidon CRO staff offers a wide range of academic competence and solid experience of clinical research, as well as of working with global pharmaceutical and biotech companies, and of interacting with the various regulatory authorities in the Nordic region.
All our staff has medical/scientific backgrounds and continuously undergo documented training.

Services

The objective is to provide evaluation tools for trial feasibility, in order to:

  • Feasibility and Patient Recruitment

  • Regulatory and Ethics Committee submissions

  • Clinical Monitoring and Site Management

  • Project/Study/Site Management

Feasibility and Patient Recruitment

Slow site start up and patient recruitment is the most common cause of delays in clinical studies, a field of activity in which every single day , counts.
Our orientation regionally focused with local CRO with expertise in each location we cover, our wide-ranging local networks include investigators both in the private and the public healthcare system.
We use a well-defined process when selecting sites, using study-specific questionnaires, thorough feasibility assessment and evaluation of the potential sites; all to ensure a high probability of reaching the required number of patients for the study within the specified timeline, avoiding confusion and competitive recruitement , and minimizing the risks of recruitement failures.

Our main interventions in this field are :

  • To obtain information from a local indication on the feasibility of the clinical trial.

  • Identify the environment where the clinical trial will be carried out.

  • Identify the targeted population for the recruitment phase of the clinical trial.

  • Confirm the timetable of clinical trials processes.

  • Make an enlightened decision based on the distribution of sites of the clinical trial.


Regulatory and Ethics Committee submissions and contacts

We handle the regulatory and ethics committee submissions and contacts in all the covered countries, using our local experts.
This includes local mandatory regulations, such as Patient's welfare acts, Personal Data Act and Radiation Committees regulations.
Our knowledge of local ethics and regulatory requirements is invaluable in reducing approval process timelines , which would be long if additional querries are issued to re assess the submitted dossier.

Clinical Monitoring and Site Management

Poseidon CRO offer highly experienced Clinical Research Associates (CRA).
Our project teams collaborate closely with our sponsors, and maintain close contact with the sites, supporting each investigator in order to maximize quality and performance.
Study sites in all the covered countries are within easy reach of our CRAs, facilitating coordination and operational efficiency.
Studies are carried out according to current regulations and guidelines. Additionally, ICH-GCP, local ethical requirements, Sponsor's SOPs as well as all procedures and data collected are subject to our in-house Quality Assurance continuous support.
Wether it is physical or remote monitoring , we adopt a risk based approach in identifying with you the monitoring needs and implement the proper plan and frequency for each study.

Study Management

Comprehensive project management is the key to the success of any study.
We have teams of experienced and well-educated Project Managers present in all covered countries.
Our Project Managers maintain an overview of all aspects of the study, working closely with the study team to ensure control of project scope, quality, budget and timelines.
All our processes are part of a global quality management system , spread through out the covered region and within partner companies to deliver high quality , minimising discrepancies , integrating changes and tracking excellence.

Phase I : Coming soon

Phase II :

Our highly trained team of biostatistics, pharmacology and early phase research experts can proceed to the design of a short-term evaluation of Pharmacokinetics and Pharmacodynamics of your product with mastered protocols of sampling , measuring and analysing data ; allowing a useful insight for the choice of the optimal dose(s) and the search for (drugs/meals)interactions .

Phase III , Patient Retention and interest for research in Emerging Markets Investigators :

Participating in a trial (Phase III) during a multicentric investigation is what physician researchers look for to back up their CVs.
The benefit for manufacturers is to prove their products tolerance and efficacy in the concerned indication and to be in conformity with MA.
It is understood that the patients participating in such studies benefit from free treatment of their pathology, in which coverage can continue even for two years after the completion of the clinical trial, under “a compassionate use” programmes provided by law in majority of areas covered.

Phase IV and Post Marketing Studies :

These studies allow researchers to examine situations concerning the use of drugs on a large scale and will enable to:

  • Enrich knowledge of scientific community and regulatory authorities about Pharmacovigilance.

  • Promote medical practitioners’ knowledge of the products and to enable them from building a well-studied attitude of an experienced, analytical user that will impact positively their adoption of the product.
  • Dispose of leading patients with medical files used for statistical scientific purposes, research, decision- healthcare policy making or as a support for market planning of manufacturers that lets them be ahead of the competition.
  • Post-marketing studies also are an inexhaustible source for data concerning Pharmacovigilance and objective and subjective discretion of a new product by doctors and patients.

  • We observe the strictest ethical rules among our entire studies and specifically the post-marketing studies in which investigators are paid for the worthwhile data that they gather and not for the number of participating patients.
    The inclusions should imperatively correspond to the targeted medical indications and to forwarded proven statements.

Therapeutic Areas :


Therapeutics Areas Clinical Phase
Rheumatology Phase III b, Phase IV
Haematology-Oncology Phase IV
Pneumology Phase IV
Hepatology-Virology Phase IV
Oncology Phase II, Phase III
Neurology Phase III , Phase IV
Rare diseases Phase III
Cardiology Phase IV

Additional Clinical Services


The Donation programmes

To strengthen the brand image and the recognition of the product among the community of doctors and patients, donation programmes are addressed to patients without health insurance coverage, who need therapy and who are not given entitlement to reimbursement of healthcare costs by local national medical insurance funds , in many countries of coverage.
We take care of the programme conceptualisation, implementation and follow up, along with checking the participants’ eligibility and ensuring the compatibility of drugs through paying monitoring visits and regular reporting of the participating centres.
Such a third party approach gives more consitency to the social responsability of the manufacturer/importer and permits to gain in confidence among beneficiaries and health care providers.

Patients’ Access Programs

For specific therapeutics with interlinked processes(hospitalisation for biotherapy infusion, anti-cancer chemotherapy, immunosuppressive drug bolus for patients whose mobility is impaired (MS, etc),we initiate coordination programmes with patients, prescribing doctors, social safety organisations and health facilities, so that the patients’ access to their treatment and drug administration occurs in optimal conditions.
Particular knowledge of KOLs (Key Opinion Leaders) for each speciality and a control of legislations holding the administrative handling of a drug dispensation and liberation (central pharmacy , national insurance, ministry of health ...) help us be catalysts of Market Access for early beneificiaries.
For all our assistance programmes for patients, a regular update on access, patients, accountancy of drugs and the mapping of of prescribing doctors , as well as degree of collaboration and adoption are provided.

Compliance Reinforcement programmes for special therapeutics

This program is dedicated to patients who are treated for chronic diseases (hypertension, diabetes , HIV , HCV , CLM whom are requested to be strictly compliant with the drug regimen...).

Wether call center based, Web -based , physical center based ; all our approaches are legislation compliant and patient centric in order to help them accomplish better compliance and though better treatment results.

The attending physician benefits from this program that helps him/her to better follow up these patients during consultations through accessing an available database containing historical patients monitoring using a mobile app , an interactive website or better intellgent blister technology using NFC tags .

A paramedical trained person accompanies the patient in local language , throughout the program in a continuous education perspective to explain for them their illness, the side effects of drugs and remind them of the time and maaner of taking the medicines and of any other particular precautions.