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Study Site Selection

User Manual for Investigators download

Dear Investigator,

This platform will give you and your colleagues a global visibility to participate in clinical research projects.

We´d like to ask you to let your colleagues participate and explore the advantages of EasyClin© themselves, by inviting them to register on our platform for free.

Dear Sponsor,

This platform offers a simple and cost-effective way to evaluate the feasibility of clinical projects at different study centres. This reduces and controls the risks associated with clinical project placement, avoids errors and, in the best case, prolongs product marketing cycles by bringing the products under investigation to the market earlier.

Without claiming completeness, the system is aimed at all researchers conducting clinical trials. This applies to all prospective studies of all clinical phases, as well as any kind of non-interventional study.

If you are happy with EasyClin© tell it to others, if not contact us. We are constantly working on improvements and are happy to receive customer feedback.

sales@easyclin.com

Introduction

In the year 2017 and in view of the imminent implementation of the European General Data Protection Regulation, the question how feasibility studies should be carried out in accordance with the new regulation, and more precisely how to give all stakeholders full access to their own data, arose. Based on these considerations, we have devised a system to carry out these evaluations quickly, cheaply, and securely. We are proud to make this product available to you as an independent system.

Your entry to a new world of study site selection – faster, cheaper, better and EU-GDPR conform. By using this networking platform as as sponsor you will find all your information about all you companies feasibility trials at one place. While it works in the same way for your investigational sites the burden and work load to participate in clinical trials will reduced significantly.

The Clinical Trial Feasibility study evaluates the possibility of conducting a particular clinical program / trial in a particular geographical region with the overall objective of optimum project completion in terms of study site competencies, patient population, timelines, targets and cost.

Sven Engel, CEO – CIO SynapCon Ltd.

Seko Williams, COO SynapCon Ltd.

Short introduction for investigators / study sites

Registration (pro-active)

Investigators can register pro-active on the entry portal to the global investigator list (Study Site Selection) or upon invitation to participate in a feasibility project.

Once you have completed the information needed for you registration you will receive an email confirming the registration.

Registration (invited by sponsor / CRO)

With your personal invitation from the sponsor or contract research organization of a clinical research study you will receive the log in details to EasyClin(c) feasibility. After you log in to the system you will be asked whether you`d like to become part of the global researcher’s community or not. In every case you remain the owner of your personal data.

Invitation to participate in a feasibility study

In case you are already registered on the global list you will be invited without any additional log in details. Please use your known login information.

Dashboard

After logging in to the system you will first see all projects you have participated in in the past, as well as all active projects.

Frequently Asked Questions (FAQ)

Here you will find a collection of possible questions and requests from users. We try to record all questions promptly and answer them comprehensively. Please address your questions to service@easyclin.com.

Short introduction for sponsors / CROs

Introduction – Feasibility Studies

Feasibility Studies (site selection) are pieces of research done before a main study in order to answer the question “Can this study be done?”. They are used to estimate important parameters that are needed to design the main study. The design of a feasibility study generally involves listing those parameters which are uncertain and describing the methods for improving their precision so that the main study will have a better chance of success. Examples of such parameters include:

  • standard deviation of the outcome measure, which in some cases is needed to estimate sample size
  • willingness of participants to be randomized
  • willingness of clinicians to recruit participants
  • number of eligible patients
  • characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure
  • follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc.
  • availability of data needed or the usefulness and limitations of a database; and
  • time needed to collect and analyse data.

Feasibility studies for randomized controlled trials may not themselves be randomized. Crucially, feasibility studies do not evaluate the outcome of interest; that is left to the main study.

The platform concept

EasyClin© feasibility is available as a cloud solution. Our servers are in server farms in Germany and are subject to the strictest security requirements.

This system is strictly following the philosophy of networking for better research. Following this approach, we do not offer a private cloud or white label solution.

For questions about the system and related business opportunities contact our team at sales@easyclin.com.

Your study physicians regain control over their own data

Registration

After you registered to the platform (Study Site Selection) the limited functionality is available to gain initial experience. 

Use the account settings to activate the full version. This will give you the unlimited access to the global list of study sites*, the full reporting functionalities and the manuals (SOP feasibility studies, SOP risk management and the user manual). 

The one-time activation fee is 250 Euro. This will be charged again after 2 years of inactivity.

Dashboard

After logging in to the system you will see all your companies’ active and past projects.

The dashboard is a powerful information tool and the starting point to create your feasibility projects.

Sponsor / CRO Specific Study Sites

The study sites of the clinical research organizations are stored here.

From this list you can select the examiners to be requested.

The research organization is responsible for compliance with the data protection regulations. The investigator requested for specific projects must agree to the use of their data, which ensures compliance with the legal framework.

Global Study Sites Registry

Companies that use the system can select investigators from the global investigators list. All investigators on this list have agreed to be eligible. Most of the investigators on this global list have experience in clinical trials. However, all the information provided here comes from the study centres. We do not review the content on a regular basis and accept no responsibility for the information provided.

Create a new project

In the first step, please enter the relevant information from your draft of the study synopsis into the input mask.

The information entered will be used for the invitation letter and the questionnaire.

It is important to decide whether you want to add a non-disclosure agreement or not. This depends on the secrecy status of the provided information. If you are unsure, we recommend not to de-select “NDA required.

Define the feasibility questionnaire

After opening the “Questionnaire” tab, you can create a new questionnaire.

At the beginning of your work with EasyClin(c) feasibility, you start with the template created by us. The number of templates will increase with the frequency of use of your company.

After selecting the template, you can define additional questions. 11 questions, which represent the classic questions, are predefined. Only these questions are included in the risk assessment. You can define any number of questions. Please note that this is only a feasibility study. We recommend a limitation to a total of 15, max 20 questions.

Add necessary documents to your project

Upload the information you have chosen with your team to provide to the investigators. Please check again if the activation of the non-disclosure agreement is needed or not.

Assign and invite study sites

In this section you can add the study sites you would like to invite for your feasibility study.

Investigators from your personal list without an own account at the global list receive an invitation with the link to the feasibility system, username and transient password included**.

Investigators already registered on the global list also receive this invitation via email, but without new access details.

Closing Remarks

We are convinced that we have presented a tool for managing feasibility studies that is convincing in every respect.

For the first time, you now have a permanent overview of all feasibility studies carried out in your company. This gives you a clear competitive advantage and significantly reduces costs and expenses from the very first use.

Please direct your questions to: sales@easyclin.com

Your EasyClin Feasibility Team

October 2020

  • *The global list of study sites evolves over time and is an additional, free, benefit for sponsors and CROs
  • **5 invitations are for free. The price per additional invitation is 60 €.