Tag Archives: data managers experts

Becoming a Data Scientist {EDC Developer + Statistical Expert + Data Manager}

At an early age, I was drawn to computers. I did well in math; I love science and I started enjoying programming when my stepfather gave me a small computer to program games. This was my real experience with programming. I think the programming language was Basic. The computer had some built-in games and basic math problems in it but you could also play around with ‘Basic‘ codes and create your own.

Then I went to a technical school and into college where you take basic classes in information system /technology and took courses in telecommunication management.  Most of the courses were around IP, PBX and Network Administration.  As part of that curriculum, I took a basic programming course and VB.net. I really like that since it has a visual interface (drag and drop to create the interface) and when you click a button you create an event so I like the design aspect of it (I am known to be very creative) then I started to design for people (website design and development, small databases). A lot better than working in telecommunications. I thought VB was a great first language to learn. Later I took a Microsoft Access database development class and we learn database design (relational) and found out I was really good at that.

Before I graduated, I was already working for a well known pharmaceutical company as a database analyst within their data management and biometrics team. They really like what I did with their clinical operations data (investigator data – you know the one that now we need CTMS systems for nowadays). So this was a confirmation that ‘databases’ was my passion. I love designing it, managing and maintaining it.

During my early years in this industry, I spent a lot of time writing SQL codes and SAS programs.  We pulled the messy data (back in those years we used the Clintrial Oracle backend system) and very problem solving oriented. A business question was asked and we would go using either SQL or SAS and go into this messy database and figure it out the answer. I really enjoyed that.

In recent years, I take data from a {EDC} system then write scripts to summarize the data for reporting and put into a data warehouse and then I use a product called ‘IBM Cognos’, which points to the data warehouse to build those reports and worked with different users across different departments (a lot of different audiences for the data) with a lot of different interesting data in there. I have spent time using APIs to extract data via Web Services (usually in XML-ODM format) and generate useful reports in SAS or Excel XML.

People think that being a data analyst is just sitting around a computer screen and crunching data. A lot of it is design-oriented, people-oriented, and problem-solving. So when people ask a question, I get to dive into the data and figure it out the answer.

Next step is to get into predictive analytics and do more data mining and data forecasting.

Are you still excited about becoming a data scientist?

You can start by reading my blog about programming languages you should learn here!

Other tools and programming languages you should learn: Anaconda, R Programming, Python, Business Intelligence Software like Tableau, Big Data Analytics with Hadoop, create new representations of the data using HTML and CSS (for example when you use APIs, XML to extract data from third-party sources).

Anayansi, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical, Biotech, and Medical Device industry with more than 18 years of experience.

Available for short-term contracts or ad-hoc requests.  See my contact page for more details or contact me.

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

7 questions to ask yourself before you choose to set up your own Clinical Data Management department

The arguments to set-up your own Clinical Data Management department are various. You want to learn something new. You can do Clinical Data Management yourself because you could allocate resources for it. Conducting Clinical Data Management in-house could get you more in control of your clinical study data. Clinical Data Management done in-house could cost you less. You could perform Clinical Data Management better yourself. You want to spend your Clinical Data Management budget internally. You see a chance to make (more) money. You see a chance to (better) serve your Customers. You want to complete the gap in your clinical service(s).

Before you make the final decision you could ask yourself 7 questions:
1. For what type of studies should I want to conduct clinical data management myself? For all the studies I conduct? For the first clinical trials in the market application process? For phase III/IV clinical trials? Or for clinical studies conducted post registry?

2. Does a Clinical Data Management group fit in, and does it add value to my company’s core business? Is dedication to the Clinical Data Management performance part of my daily business targets?

3. Do I have enough studies, enough workload for Clinical Data Management to return investments? Is the cost-benefit ratio in my advantage?

4. Can I allocate enough resources, e.g. time, capacity, knowledge and money to the Clinical Data Management department to get clinical data quality from it?

5. Is this the right moment? Right now, should I invest in setting up a new department in my company? Is my company ready for the next step; an own Clinical Data Management group?

6. What are the benefits for my organization when we can conduct Clinical Data Management ourselves? What will it bring us?

7. What are the requirements for this Clinical Data Management department regarding the type of studies and the amount of studies. What are our user requirements for a Clinical Data Management system(s)? What is the capacity we need to handle that Clinical Data Management system and what information do we need?

The number one question in my experience; is a Clinical Data Management department a logical fit within your companies core dedication? Logical like ‘clinical research to get your products accepted for marketing’ or ‘providing clinical research services’. Dedicated Clinical Data Management can start returning investments.

Source:

This is an ezine of Maritza Witteveen of ProCDM. For Clinical Research Directors who struggle with clinical data management to get reliable, quality clinical study data successfully. Receive tips and the free e-book ‘Five strategies to get reliable, quality clinical data’ by subscribing via http://www.procdm.nl/pages/knowledgebase.asp.

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Fair Use Notice: This article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

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

How to write query texts – 6 template sentences

How to write queries unambiguously expressing what is asked for? Using short, polite sentences? Objectively explaining the underlying inconsistency?

First of all my general guidelines.

My preference is to use no more capitals then needed. Capitals in the middle of a query text, e.g. for CRF fields or for tick box options, could distract from getting the actual question asked. E.g. compare the same query texts, with and without extra capitals. Please verify stop date. (Ensure that stop date is after or at start date and that stop date is not a future date.) Please verify Stop date. (Ensure that Stop date is after or at Start date AND that Stop date is not a future date.)

Referring to CRF fields as they are shown on the CRF. To easily find the involved field(s).

I prefer to leave any ‘the’ before a CRF field referral out of the query text. For more to-the-point query texts. E.g. compare the same query texts, with and without ‘the’ before data fields. Please verify stop date. (Ensure that stop date is after or at start date and that stop date is not a future date.) Please verify the stop date. (Ensure that the stop date is after or at the start date and that the stop date is not a future date.)

Consistency in phrasing a query text can help to quickly write query texts or pre-program query texts in a structured, familiar way. That’s the thought behind the following 6 template sentences for query texts. Which you can use to help you write or program your queries.

The six ‘template’ sentences for query texts:

Please provide…

For asking the study site people to provide required data from patient care recordings. Examples: Please provide date of visit. Please provide date of blood specimen collection. Please provide platelet count. Please provide % plasma cells bone marrow aspirate. Please provide calcium result.

Please complete… For asking the study site people to complete required data as required by the study CRF design. (Not necessarily required for patient care). Examples: Please complete centre number. Please complete subject number. Other frequency is specified, please complete frequency drop-down list accordingly.

Please verify…

For asking the study site people to check date and time fields fulfilling expected timelines. Or for asking the study site people to check field formats. Examples: Please verify start date. (Ensure that start date is before date of visit.) Please verify stop date. (Ensure that stop date is after or at start date and that stop date is not a future date.) Please verify date of blood specimen collection. (Ensure that date of blood specimen collection is before or equal to date of visit and after date of previous visit.) Please verify date last pregnancy test performed. Please verify date of informed consent. (Ensure date of informed consent is equal to date of screening or prior to date of screening.) Please verify date as DDMMYYY.

…., please correct.

For asking the study site people to correct a data recording inconsistent with another data recording. Example: Visit number should be greater than 2, please correct.

…., please tick…

For asking the study site people to complete required tick boxes. Examples: Gender, please tick male or female. Pregnancy test result, please tick negative or positive. Any new adverse events or changes in adverse events since the previous visit, please tick yes or no. Laboratory assessment performed since the previous visit, please tick yes or no. LDH, please tick normal, abnormal or not done.

Please specify…

For asking the study site people to specify the previous data recording. Examples: Please specify other dose. Please specify other frequency. Please specify other method used. Please specify other indication for treatment.

Finally, for query texts popping up during CRF data recording, it could be helpful to put location information in it. Like: Page 12: Please verify start date. (Ensure that start date is after or at start date on page 11.)

Good luck finding your way to structure query texts…

Source:

This article is written by Maritza Witteveen of ProCDM. For clinical data management. You can subscribe to her blog posts at www.procdm.nl.”

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on latest news, articles, and tips. I am available on LinkedIn. Connect with me there for technical discussions.

Fair Use Notice: This article/video contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law. If you wish to use this copyrighted material for purposes that go beyond fair use, you must obtain permission from the copyright owner. Fair Use notwithstanding we will immediately comply with any copyright owner who wants their material removed or modified, wants us to link to their website or wants us to add their photo.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.