Members of our team with expertise in regulatory requirements for Turkey in
which you want to start the clinical trial will provide you with the list of
documents required, specific country regulations and timelines for submissions
and approval. Starting from contract negotiations, translation requirements and
compilation of submission files, we will ensure proper submission with complete
and quality documentation.
IDEAL Pharma Consulting has capabilities to
assist sponsors with all aspects of the clinical trials, including the
following activities:
o
Bioavailability and Bioequivalence Studies - We have the required expertise
to assist in organising and conducting your Bioavailability and Bioequivalence
Studies.
o Biosimilars Testing
Services - Our services are specifically tailored, enabling biosimilar safety
and efficacy testing including bioanalytical (immunogenicity) to demonstrate
comparability and similarity of the biosimilar product to a reference or
originator biologic drug. The Regulatory Group within IDEAL Pharma Consulting
is well placed to support sponsor companies in designing clinical trials and
critically important immunogenicity screening during clinical studies from
initial scientific consultancy regarding guidance from the regulatory
authorities, to the conception of a clinical development plan through to
Marketing Authorization, and the entire scope of Regulatory Activities that can
be performed.
o Phase I – IIa clinical
trials – We have the experience to perform all other Phase I – IIa clinical
trials, quickly and efficiently in healthy and special populations. Our
extensive database ensures rapid study participant recruitment.
o For Phase IIb –IV as
well as observational clinical trials we offer a full range of services
including site selection, project management, patient recruitment, study
monitoring, data management, biostatistics as well as global safety and
pharmacovigilance.
o During your study, high
quality and timely bioanalytical results are critical. IDEAL Pharma Consulting’s
partner scientists have the expertise to solve the most complex bioanalytical
problems, for small or large molecules, using techniques from GC, GC/MS/MS, and
LC/MS/MS to ELISAs, RIAs, immunoassays, and biomarkers.
o
All documents required for Ethics Committee (EC) and TITCK (Ministry of
Health) submissions of the trials are prepared and the submissions are
followed-up by IDEAL Pharma Consulting.
Our services include:
Study organisation/coordination
o
Time scheduling and monitoring of dates (protocols, approvals, approval of
narcotic drugs (where applicable), shipment of study medication, clinical part,
shipment of study samples, analytical part, biometrics, reports, documentation
and archiving)
o Preparing of status
reports for the sponsor and exchange of information between involved parties
o Shipment of study
medication and study samples under temperature controlled conditions
o Audits (system audits,
study audits)
o
Monitoring of studies
Study Management
IDEAL Pharma Consulting is involved in the
conduct of studies. This could be related to the complete study performance or
only parts of the study (e.g. preparing of protocol, clinical part, analytical
part, data evaluation, audits, monitoring, biostatistics, preparing of study
report). The studies refer to investigations on bioequivalence and
bioavailability (e.g. influence of food, PK-interaction, dose proportionality)
in healthy subjects and patients as well as performing clinical trials with
biosimilars.
Our staff in IDEAL Pharma Consulting has experience in the conduct of more
than 400 Bioavailability and Bioequivalence studies and provides along with
study management the following services.
Study planning
o
Development of suitable study programs and study designs
o Selection of
bio-analytical site and clinical unit
o Study protocol
preparation
o
Compiling and submitting the relevant study documents to authorities and
ethic committees
Study documentation
o
TMF and documentation according to GCP
o
Medical Writing
Site management and monitoring activities
With a team of highly
qualified and trained monitors (internal or with the collaboration with
external monitors), IDEAL Pharma Consulting team ensures strict compliance to
protocol, GCP and regulatory requirements.
Data Management & Biostatistics
Without clean, reliable
data, no trial can be successful. Our experience enables us to precisely pair
technology and proven processes with clinical studies and to help streamline
the route to more efficient and effective solutions.
IDEAL Pharma Consulting's data management
partners know that one key to your product's success is robust, high-quality
data. Our quality control checks are inherent in the processing of data in all
stages of computerization and clean-up.
Our partner
biostatisticians have a broad knowledge base in all aspects of clinical trials,
from the initial stage of planning the design and calculating sample size
requirements, to analyzing, displaying and interpreting data in the final
stages of the study. IDEAL Pharma Consulting's partner
experts provides following services:
o
Statistical part of study design; sample size estimation
o Generation of random
codes using SAS®
o PK-Data Evaluation
o Evaluation of
PK-parameter using WinNonlin®
o Preparation and table
based aggregation of individual data
o PK-data report including
all individual data, tables and graphics
o Calculation of
in-vitro/in-vivo correlation (IVIVC)
o
Statistical Analysis
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