is your reliable partner in remote and on-site services. Our most characteristic feature is the “Know How & Know Who”. We enhanced site relationships and data quality. 
offers you tailored solutions with patient centric platform. We have a global mind but think of the local at heart.
Consulting
APICES consulting services are supported by a team of experts in all the different fields of the clinical research and investigational product development.
APICES helps improving investigational products development optimizing the processes and activities of clinical research giving advice in the following fields, within others: Basic research documents; NDI report support; HHAA/IRB/EECC requirements; Applicable regulations in clinical research; Development of product research areas; Start-up Planning; Project planning; Public Grant process; Site/ Investigators/ EECC selection; Outcomes analysis.
Training
APICES offers customized courses in:
> Clinical research methodology.
> Biostatistics.
> Critical reading of scientific articles.
> Guidelines for Good Clinical Practices.
> Guidelines for Good Pharmacoepidemiology Practices.
> Clinical investigation of medical devices for human subjects – Good Clinical Practice – ISO14155:2020.
> Regulatory updates.
APICES’ Health Professionals on Good Clinical Practice (GCP) course.
The purpose of the course is to encourage and facilitate the development of quality independent clinical research, providing investigators with the necessary knowledge to ensure compliance with GCP standards. In this sense, the fundamental objectives are:
Talent Acquisition
provides a wide range of professionals within Clinical Research field, who may be working home based, or in your company with close follow up and support from .
We provide tailor-made resources to each of our clients so that they feel that they work as a professional members of your team.
Market Access
We design and manage entry agreement’s tools to monitor financial schemes and performance-based agreements between Marketing Authorization Holder (MAH) and payers at local, regional or national level, including but not limited the following features:
> Managed entry scheme monitoring / control.
> Scheme database design, set-up and management.
> Drug stock and dispensations within hospitals.
> Patient’s outcomes registry.
> Reimbursement control.
> User profiles: e.g., MAH, payer, pharmacist…
> Training procedures programs.
> Database export to client platforms.
> Generation of reports as per client’s needs.
Design and management of clinical studies included into market access programs to maximize your product value against payers: Real world evidence studies; Late phase programs; Patient registries; Observational studies; Pharmacoeconomy studies.
Implementing mechanisms to enable patients with an unmet medical need to be provided with access to a medicine, prior to the medicine is commercially available in a country.
> Activities: organization, leading meeting, conclusion, and analysis reports.
> Methodology: e.g., meta plan.
> Issues (product/therapeutic area/company): e.g., emerging markets, developed markets, stakeholders, markets access framework, strategy, positioning, pricing & reimbursement…
> Attendees: e.g., decision makers, stakeholders, HHAA, doctors, pharmacist, investigators payers, nurses…
