Tag Archives: Biotechnology and Pharmaceuticals

EMA and The Netherlands Biopharm Opportunities

The European Medicines Agency (EMA) is relocating from London to Amsterdam.

According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands.

On Friday, 13 April 2018, the Dutch Council of Ministers agreed to sign the document.

Amsterdam – EMA

Quantify research reported earlier this year that the shift of the EMA to Holland will be a welcome boon to that country, particularly due to some companies shuttering their Netherlands locations in favor of other European countries. The research report pointed to more than 1,500 job losses about eight years ago following Abbott and Merck Sharpe and Dohme closing facilities in that country. Between 2009 and 2014, Quantify said the Dutch market share in the European pharma industry plummeted from 3.3 percent in 2009 to 17 percent in 2014.

To help spur the resurgence of the Netherlands pharma industry, the Netherlands Foreign Investment Agency is hosting a landscape tour at the end of summer to showcase the country’s offerings. While the EMA is expected to become the core of the Netherlands biopharma industry, the NFIA said the country is home to facilities for more than 420 biopharmaceutical companies, such as AstraZenecaJanssen, MSD, Amgen and Teva, to name a few. The Netherlands Foreign Investment Agency pointed to the companies because they “rely on their Dutch operations for both R&D and distribution activities.”

But, it’s not just the large global pharma companies that have a home in Holland. The country is also home to a number of biopharmaceutical startups and scale-ups, like GalapagosGenmabPharming and uniQure.

Another company that will be relocating to the Netherlands is Gilead Sciences.  This new facility will be employing over 300 people. Other companies worth mentioning are GSK-Novartis, Merk and most well-known Clinical Research Organizations (CROs) have made the Netherlands their home.

For those interesting in working and living in Amsterdam, you should know that it is one of the countries with the highest taxes at a 52% income tax rate if you make over 55,000 euros per year (apparently they think this is good money). For a regular employee with benefits, your tax rate will be at a 42 %. Don’t expect to be making more than 55,000 euros a year unless you are a highly skilled employee or hold a managerial level position.

Tot Ziens!

Source:

Biospace

EMA

https://www.government.nl/latest/news/2018/04/23/the-european-medicines-agency-ema-and-the-netherlands-agree-on-seat-agreement

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Before Your Trial Goes Live – InForm FastStart

When EDC is used in a clinical trial, electronic case report form (e-CRF) data are defined to be the data that are manually entered into a computer by the patient or by the investigator’s staff.

CDISC defines e-CRF as a CRF in which related data items and their associated comments, notes, and signatures are linked electronically.

e-CRFs may include special display elements, electronic edit checks and other special properties or functions used for both capture and display of the linked data.

Prior to submitting a request – FastStart, you should throughly test your trial.

Technically speaking, FastStart requests ensures base is cooked when sending all UAT versions of the trial, Training and Production versions of the trial to Oracle implementation team. This will vary on the type of contract your company / sponsor has with them.

Your company or sponsor may have a setup of ‘Implementation’ instructions that will be provided to Oracle HSG (formerly PhaseForward) that includes all files, summary and instructions for each implementation. Some of these required files or special files are listed below.

Special Files:

Filename Contents
Customresources.XML Collects references to any html files that will be use to override standard InForm functionality within the trial. Includes the visit calculator (VISITCALCULATOR.HTML) and confirmation of enrollment message (ENROLLMENTCONFIRM.HTML).
InsertUsers.XML User details
InsertSites.XML Site details
InsertSiteGroups.XML Links users with specific sites
InsertGroups.XML Defines the properties and contents of groups e.g. queries, items
InsertRightsGroups.XML Groups multiple access rights, with details of specific users that are assigned those rights.Also contains details of any overrides to default levels of access at item level
InsertSignCRF.XML Defines form to be signed and group who have access to sign
Crbaffadavit.TXT Affadavit text which appears when signing the eCRF (used at eCRF level). The text is standard, but protocol number must be amended for each trial. NOTE: This file will be used for any trials using casebook level signatures.
logo.jpg Your company logo
EnrollmentOverride.htmlHomedefault.html Here you can modify your trial name

The eSignature is a replacement for the Investigator’s physical signature (paper form). This file captures confirmtion from the Investigator that he has reviewed and confirmed the information on each eCRF is accurate. This Affidavit text contains something like ‘I, Principal Investigator, for study 9999999, confirm I have reviewed this CRF form….’

Investigator– 21 CFR 50.3(d) defines the investigator as “The individual who actually conducts a clinical investigation – i.e., under whose immediate direction the test article is administered.”

Some recomendations about eSignature can be further research on Secure Access For Everyone (SAFE) standards. The goal is that once the investigator is credentialed by SAFE, his/her identity and electronic signature can be used by all SAFE compliant sponsors.

InsertUsers File

Training must be provided to sponsors users prior to granting access to an InForm trial. For example, CRAs will need to be well trained on all aspects of the EDC system in order to provide coaching for the investigator. This file documents all sponsors and site staff users within each clinical trial.

Easy, wasn’t it? Again, build your trial and test to make sure all files were cooked and working as expected. Log into your trial and ensure that the special files appear correctly. Enroll a subject to ensure the enrollment confirmation screen appears and, if used in the trial, the visit calculator appears.

Reference:

Electronic Clinical Data Capture, Position Paper Revision 1, May 1, 2005

How to manage Sites and Users in InForm Trial

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

ClinCapture® Tutorial – How to enter a patient schedule a visit and start entering data

ClinCapture® Tutorial – How to enter a patient, schedule a visit and start entering data – YouTube.

ClinCapture® is the most advanced open-source electronic data capture (EDC) system designed to streamline your clinical trials. As an open-source solution, ClinCapture® is tailored to meet the needs of life science companies looking to run cost-effective clinical trials.

ClinCapture® can be rapidly deployed and easily adopted, customizable to specific study requirements. ClinCapture® is repeatedly chosen as a preferred EDC solution because it is intuitive, flexible, and proven.

Source: Clinovo

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How to Manage Sites and Users in InForm Trial?

So you created your first InForm Trial and now what? Before you can actually enter data into your trial, you need to set up a user management system which assigns permissions to different users in your system depending on their job “role”.

In InForm, this is accomplished by using a tool called ‘User Management Tool’ or simple UMT. This tool allows sponsor to manage sites and users once the trial have gone live. There may be many different user groups with different levels and ranges of permissions.

Creating an InForm Trial – UMT:

  1. Create your InForm trial in the UMT. I won’t go into details on how to actually do this and depend upon the contract agreement with the vendor (i.e. Oracle/PhaseForward); they will perform this task for you.
  2. Select Trial Version = latest InForm version (i.e. 5.0)
  3. Select Countries where this trial will take place
  4. Select Status. Each InForm trial has 4 main statuses.
    1. Fast Start = Pre-Go Live
    2. Fast Forward = Trial is now live
    3. Fast Lock = Trial is lock
    4. Decommission = Trial is completed/archived

Managing users and groups can be a tedious task but tools such as UMT makes them easier to manage.

Roles: Roles (e.g. CRA, PI, System Administrator, etc) are used to assign specific permissions to individual users or groups, typically to perform specific functions in the InForm system.

The system allows you to either manually enter a role or import using a template called ‘MUL’ or Masters Users List. If you decided to upload your rights and roles via MUL, the system will generate a log file. It is imperative that you check this file and check any errors before proceeding.

Once the roles have been added to the UMT, you need to approved them before you build your clinical trial. The system also comes with defaulted and approved rights and roles.

Another option available is to create what is called as ‘signature groups’. If you are familiar with Medidata Rave system, this is equivalent to checking the ‘Signature required’ box and setting the investigator signature in Architect project main page.

Common use of Signatures in clinical trials are at the form level (i.e. 1 signature per form or at the subject level or studybook = 1 signature per subject).

Item Groups: Items groups is used to overrides or restrict a particular user access to a form or field. This is equivalent to ‘Restrictions – View/Entry’ in Medidata Rave.

One good example of display override usage is the coding fields restrictions. If only Clinical Coders are allowed to view / entry data on those items, you will limit access to all roles but the coders role.

Here’s a snippet of the code in .XML:

<!–?xml version=”1.0″?>–>
<MEDMLDATA xmlns=”PhaseForward-MedML-Inform4″>
/*some other code goes here*/
<ITEMGROUP
GROUPNAME=”Hidden Coding Items”
GROUPDESCRIPTION=”Hidden Coding Items”>
<!– Insert ItemRef Names –>
<ITEMREF REFNAME=”PT_NAME”/>
<ITEMREF REFNAME=”HLGT_NAME”/>
<ITEMREF REFNAME=”HLT_NAME”/>
<ITEMREF REFNAME=”LLT_NAME”/>
<ITEMREF REFNAME=”SOC_NAME”/>
</ITEMGROUP>
</MEDMLDATA>

Two other important groups that you need to be aware of is the Query and the Report Groups. The former, as the name entails, allows a user to open, answer, reissue and close queries during the course of a clinical trial. The latter, allows a particular user to run reports.

For example, an Ad Hoc User can access Ad Hoc reports via Cognos. The roles associated to this group could be your project manager, Clinical Research Associate (CRA) or your Lead Data Manager (LDM/CDM).

Once you have completed your basic setup, you will need to prepare or cook those xmls files onto your clinical trial. The rights/roles we discussed needs to be in an approved status. You also want to make sure you ‘lock for QC’ or lock the trial to prevent anyone from making changes to already added sites/users.

Sites and Users marked for upload to InForm will automatically be cooked into your trial.

Last step we need to take is to generate the XML files by selecting the link ‘Generate InFormXML.’ Now, your UAT trial is created, your URL is set up and you are ready to perform User Acceptance Testing.

Remember to validate your XML files, especially if your clinical trial is running across several countries. I have found issues with foreign languages symbols or special characters entered in the UMT system. Avoid at all cost any special characters.

Source: User Management Tool Reference Guide from PhaseFoward

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

Data Management Plan in Clinical Trials

 

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

The data management plan typically contains the following items. They are:

  1. Introduction/Purpose of the document
  2. Scope of application/Definitions
  3. Abbreviations
  4. Who/what/where/when
  5. Project Schedule/Major Project Milestones
  6. Updates of the DMP
  7. Appendix

The objective of this guidelines is to define the general content of the Data Management Plan (DMP) and the procedures for developing and maintaining this document.

The abbreviation section could include all acronyms used within a particular study for further clarification.

e.g. CRF = Case Report Form
TA = Therapeutic Area

The Who/What/Where/When section should describe the objective of the study specific data management plans for ABC study. This section provides detail information about the indications, the number of subjects planned for the study, countries participating in the clinical trial, monitoring guidelines (SDV) or partial SDV, if any CROs or 3rd party are involved in the study (e.g. IVRS, central labs), which database will be used to collect study information (e.g. Clintrial, Oracle Clinical, Medidata Rave or Inform EDC).

The Appendix provides a place to put supporting information, allowing the body of the DMP to be kept concise and at more summary levels. For example, you could document Database Access of team members, Self-evident correction plan, Data Entry plan if using Double-data entry systems or Paper-Based clinical trials systems.

Remember, this is a living document and must be updated throughout the course of the clinical trial.

If problems arise during the life of a project, our first hunch would be that the project was not properly planned.

Reference: Role of Project Management in Clinical Trials
Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Reasons I Like My Job

It has been a little while since my last blog. I have been busy this summer with the acquisition of a new member of our family – a 7 weeks-old White Westie. I have been most of the summer taking him to the park, riding the bike to the local beach or lake in his mini doggie ride. On top of that, I have been busy with client projects and meetings.

With my job, I work as a consultant for pharmaceutical and biotechnology companies. So what makes this job special?

Experiences

As a consultant, I get the chance to work with many clients and projects. With each opportunity, I learn a new perspective and approach that has been taken to building various clinical databases that support clinical trials. There have been a number of occasions where problems between clients are similar and this similarity allows me to bring those experiences to the next client.

Challenge

My clients don’t often bring me in for the small and easy stuff. For that, their staff usually has the capacity to handle their needs. The time to turn to consultants is when the timelines or technical depth of the project requires outside help. Because of this, I often find myself on engagements that are relatively challenging. I can really take lessons from one client and apply them to all others.

I get exposed to things I already have ‘expertise’ in and I also get exposed to things I only know academically. I get to learn!

Mentoring

I love teaching. Being a consultant provides an excellent opportunity to do this. I have been working with a lot of clients in a mentoring relationship. Sometimes in person, sometimes via webex.
I like to think I made a difference for each and one of my employers/clients I have worked for.

Freedom

One bonus of working in the Pharmaceutical industry has been the ability to exercise a lot of freedom in choosing where to move my career. As my skills and interests have changed through the years, so too have my responsibilities and assignments.
So life has been busier in some ways but it has been more flexible.

I have had more scheduled flexibility than I ever had.

So until my next post, tell me why do you like your job?

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.