Clinical Trials

We provide full-service solutions for Phase I-IV and Post Marketing Observational Studies . Ascot Science offers One Stop Shop in a One Contact opportunities their clients and work with Challenge Accepted Approach

Clinical Research Study Design

A cohesive design will maximize efficiency and minimize risks in gathering the necessary clinical data to ensure the safety and efficacy of the therapy. The planning process is highly highly complex, unique, and requires close collaboration between an interdisciplinary team of regulatory, clinical, medical, statistical, safety, and scientific experts.

Early Clinical Research Planning

Proof-of-concept scientific data

Early Pharmacokinetic information

Target Indications selected or prioritized for clinical trials

Evidence of GMP manufacture

Funding secured for clinical trials

Drug stability data

Nonclinical toxicology studies

Once you have decided to bring your therapeutic forward to clinical trials, it is then time to begin starting to plan your trials

Regulatory Planning & Medical Writing

Develop the regulatory strategy and submission plan to support both Turkey and global registrations global yerine EMA & FDA

Explore the possibility of pursuing expedited or alternate regulatory pathways for faster approval, and writing the corresponding applications

Statistical & Data Planning

Begin site & patient feasibility

Draft monitoring plans

Prepare Safety Management plans

Regulatory Planning & Medical Writing

Begin site & patient feasibility

Draft monitoring plans

Prepare Safety Management plans

Project Management

Ascot Science provides comprehensive clinical project management services ranging from single-site studies to global multi-center trials. Our Project Managers maintain personal ownership of study milestones to ensure the projects are successful, delivered on time, and completed within budget.

We provide support with;

Acting as the primary point of contact for our clients and the project team;
Providing clinical development program consulting and road mapping for successful execution;
Running in-depth feasibility studies and risk assessment plans for country evaluation, including the regulatory environment, disease prevalence, and patient access;
Ensuring strict compliance to national standards, ICH GCP guidelines, Turkey, EMA, and FDA regulations, assigned SOPs and the trial protocol;
Overseeing all functional areas and vendors;
Managing site and sponsor communication.

Regulatory and Ethics Committee Submissions

Having solid experience in Clinical Trial Application (CTA) submissions and in-country personnel across Europe and the EMEA region, Ascot Science provides a full-scope service in order to ensure the successful and timely start of a clinical study.

Our team is dedicated to delivering the highest quality support, providing the following services;

Ethics Committee Initial Submissions; Ethics Committee Submissions for Amendments, Notifications, and End of Trial Submissions; Regulatory Authority Initial Submissions; Creating a management framework to optimize project execution; Regulatory Authority Submissions for Amendments, Notifications, and End of Clinical Trial Submissions; Preparation and adaptation of Subject Information Sheet and Informed Consent Forms (SIS/ICFs) in line with local requirements; Translation of all study-related documents into local languages, including quality check.

Clinical Monitoring

Ascot Science offers a tailored made service approach, taking into account the individual needs of our partners and the unique characteristics of each study.

Our services include;

Country feasibility studies and site identification and assessment Site monitoring visit activities Ethics committee and regulatory authority submissions Translation of study-specific documents including quality check Assistance in obtaining local insurance Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling, protocol, etc.) Clinical trial oversight in order to assure compliance with the protocol and applicable regulatory requirements Accurate source verification for reliable clinical data Site support on the prompt recruitment process Trial Master File (TMF) / Investigator Site File (ISF) compilation, review, and maintenance Investigational Medicinal Product (IMP) and Clinical Trial Materials (CTM) coordination; Support during site audits and inspections.

Medical Writing

Our medical writers are qualified scientists with PhD degrees in biomedical sciences with experience in the pharmaceutical industry, Clinical Research Organizations (CROs) and academia. Ascot Science ’ medical writing team can fully support clients with the preparation of the following documents required for clinical research, regulatory affairs, or scientific purposes.

Our team is equipped to help you when working on:

Clinical Development Plans Clinical Study Protocols; Investigator Brochures (IBs) and annual updates Case Report Forms (CRFs) Informed Consent Forms (ICFs) ICH GCP compliant Clinical Study Reports (CSRs), including CSR synopses for public disclosure Abstracts, manuscripts, and journal articles Medical and scientific literature reviews

Data Management & Statistical Analysis

Our Data Management team provides high-quality collection, validation, analysis, and quality control of clinical trial data. Generally, we utilize electronic data capture (EDC) to expedite data collection and enhance quality, but we can also handle paper CRFs (including printing, despatch, collection and double data entry).

Clinical Development Plans
Clinical Study Protocols;
Investigator Brochures (IBs) and annual updates
Case Report Forms (CRFs)
Informed Consent Forms (ICFs)

Clinical Development Plans
Clinical Study Protocols;
Investigator Brochures (IBs) and annual updates
Case Report Forms (CRFs)
Informed Consent Forms (ICFs)

Clinical Development Plans
Clinical Study Protocols;
Investigator Brochures (IBs) and annual updates
Case Report Forms (CRFs)
Informed Consent Forms (ICFs)

Ascot Science biostatisticians provide trial design consultation, statistical methodology recommendations, statistical programming, and analysis to create a customized approach designed specifically to meet individual project requirements.

Proof-of-concept scientific data Early Pharmacokinetic information Target Indications selected or prioritized for clinical trials Evidence of GMP manufacture Funding secured for clinical trials Drug stability data Nonclinical toxicology studies Once you have decided to bring your therapeutic forward to clinical trials, it is then time to begin starting to plan your trial(s)

Quality and Compliance

Ascot Science Quality and Compliance Assurance activities help our clients to ensure the integrity of their clinical trials and protect research subjects’ rights and welfare.

Quality Management System implementation, standard operation procedures (SOPs) development, risk management, and regulatory compliance
Auditing: planning, conduct and reporting;
CAPA plans development, root cause analysis and follow-up;
Training and quality consultancy;
Inspection readiness support;
Hosting audits and regulatory inspections.

Rescue Clinical Trials

<p> Your Clinical Trials Management should flex to fit the needs of your study. Our Clinical Trials Rescue Services team will build a personalized solution from the ground up that meets the milestones and challenges of your individual clinical trial. </p> <p> Our experts know that clinical trials strategies must support sponsors, sites, and patients while multiplying value and maximizing impact. Our global network of trusted investigators, high-performing sites, and deep patient databases, along with a myriad of customized services, helps accelerate enrollment, sustain retention, and ensure your study starts and ends on time. </p> <ul className=”red-list mt-5″> <li>Risk Management</li> <li>Patient Recruitment</li> <li>Budget Management</li> <li>Third Parties/CRO Management</li> <li>Quality</li> <li>Timelines</li> </ul>