Clinical Research Operation

ASKLEP provides total support services combined to meet the client needs in all sorts of clinical development projects, including but not limited to monitoring, data management and statistical analysis, in a speedy manner. ASKLEP analyzes operating procedures of a pharmaceutical company utilizing our profound experience and know-how in the capacity of CRO (monitoring and data management) and provides support for EDC development, implementation and operation.

ASKLEP is committed to proposing CRO business models in clinical studies well beyond the conventional framework with the addition of “consultation and global implications” as a partner of pharmaceutical companies to help them deliver new drugs to patients as early as possible.

ASKLEP’s Advantage

Service Overview

FAQs

 

Do you report the results of your voluntary audit on your outsourced services to the outsourcer?

We do not report the results of internal audits to sponsors. This is in compliance with the “Japan CRO Association Voluntary Guideline for the Proper Conduct of Outsourced Services” defined by Japan CRO Association where ASKLEP is a member.

What background do your trainers have?

Our full-time lecturers have profound clinical development experience and their background includes medical doctors, nurses, CRCs former pharmaceutical company professinals, etc.

We would like to budget the cost for training. Do you disclose necessary expenses?

Please contact our client service department and let us know your needs and request and we will be happy to provide an estimate for you.

Can ASKLEP perform medical marketing surveys for our clinical development strategy, including post approval sales forecast?

Yes, through our sister company, ANTERIO, can provide a full spectrum of marketing research for your clinical forecasting.

We are considering the conduct of clinical studies. We do not have any Japanese corporation in Japan but can ASKLEP serve as our In-Country Caretaker?

Yes, ASKLEP has submitted Clinical Trial Notifications as an In-Country Caretaker in the past. ASKLEP has all necessary functions to conduct clinical studies including but not limited to monitoring, data management and statistical analysis as core as well as regulatory affairs, medical writing and safety information. Therefore, ASKLEP is able to perform all functions necessary for a clinical study from organization development for implementation of a clinical study to writing of a clinical study report for and on behalf of your company.

Who drafts clinical study report at ASKLEP?

Personnel familiarized with clinical trials and various guidelines are responsible for medical writing. They are also familiar with statistical analysis and can provide a comprehensive report.

We are planning an adaptive design study. Can ASKLEP provide an interim analysis?

Yes, ASKLEP is flexible and if you require an interim analysis we are able to provide that no problem. We have received requests from sponsors, independent biostatistician, and administrative offices of  Data Monitoring Committee (DMC) in the past.

We are planning a PK/PD study. Can ASKLEP analyze pharmacokinetic parameters?

Yes, ASKLEP is able to provide analysis using software application for analyses of pharmacokinetic parameters (WinNonlin).

Can you use any EDC system since we have already decided on one?

Yes, we have experience using many different EDC systems that the sponsor has required us to use.

We do not have any EDC system. Can ASKLEP provide one?

Yes, ASKLEP uses an EDC system called MARVIN that is a proven CDISC compliant system that has been used with great success around the world.  We use MARVIN because of its ease of use and set-up and its cost-efficient.

We are considering a clinical study in China. Will ASKLEP be able to handle it?

ASKLEP established ASKLEP CHINA in November 2010 and has already conducted studies with monitoring as well as regulatory filing. Our local staff has an abundance of clinical study experience in China as well as a network to facilitate your clinical needs there. If you are planning a study in China, please feel free to contact us for consultation.

What is unique about ASKLEP’s monitoring system?

Our monitoring system, ASAP2, generates monitoring reports as well as many other features.

 

Features of ASAP2:

  1. Manages monitor’s activities and detects & prevents errors or missed items
  2. It tracks all reports and lets you know in real time what is completed and what is pending.  It is an on-the-fly progress management system
  3. Forms can be exported into Excel
  4. Tracks, archives and allows you to view all documents received from the site

How do you train monitors? What is the training for new monitors? Do you have any special training?

New CRAs including new grads will receive one-month intensive training on the fundamentals of GCP and related regulations, and training on diseases and pharmacology. After completion, they will then be assigned to either Clinical Research or Post-Marketing Division to receive OJT for an additional three months. From there, CRAs will be assigned to a project team which may vary depending on individual’s background such as knowledge, experience and skills. New CRAs will receive periodic ongoing training throughout their first year. Training is conducted in-house by our trainers as well as guest physicians.

Special training is planned and operated by CRAs to share various topics including information and current therapy obtained from practical experience in an effort to enhance knowledge and skills. Planning and operation by CRAs themselves demonstrate and enhance proper procedures CRAs go through in their daily work activities.

Other training includes English training, e-learning and staff exchanges , etc.