Round-Up:The 6 Hottest Blog Topics from 2017

Posted by Cytel

Dec 21, 2017 6:44:00 AM

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

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Topics: Oncology, Data Management, Cytel Strategic Consulting, Statistical Analysis, Trial Design Software, pharmacometrics, estimands, NONMEM, data science, R language


Career Perspectives: Interview with Makarand Deshmukh, Senior Clinical Data Analyst

Posted by Cytel

Nov 22, 2017 8:46:00 AM

Cytel offers a full range of clinical data management services and the team of experts is spread across the globe.

In this blog we talk to Makarand, who is based in India, to find out more about his career path, current role at Cytel and his interests outside of work. 

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Topics: Data Management, Clinical Research Services, Statistical Programming, Statistical Analysis, careers, clinical data management, clinical research


Highlights from the 2017 SCDM Program

Posted by Cytel

Oct 4, 2017 7:34:36 AM

The Society for Clinical Data Management (SCDM) conference landed in Orlando last week providing insights and key trends for clinical data managers from around the world.  In this blog we share an infographic of some of the agenda highlights along with a more detailed overview of our Alla Muchnik's contribution to the session Study Medication Compliance: Data Collection Challenges. 

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Topics: Data Management, Clinical Research Services, Interim Analyses, Clinical Data


In the Midst of this: The Data Management Perspective on the Interim Analysis

Posted by Cytel

May 4, 2017 9:07:00 AM

 As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim analyses.  To ensure success in what are often complex studies, data management as well as statistical expertise is required.  Cytel data managers are well versed in the various nuances and demands of managing the successful delivery of an interim analysis from a data collection point of view. 

Success from the data management standpoint depends on three core elements- effective timeline management, thoughtful database design, and a proactive approach to data cleaning. In this blog, Patti Arsenault, our Global Head of Data Management shares her thoughts.

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Topics: Data Management, Interim Analyses, EDC


The Data Management Plan Takes Center Stage- why is it so important?

Posted by Cytel

Mar 15, 2017 8:51:00 AM

 

A precise and thorough approach to planning is key for success in data management.

The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when to expect it.

The Society for Clinical Data Management (SCDM)‘s publication, Good Clinical Data Management Practices (GCDMP) (1), provides a complete chapter on Data Management Plans. (The GCDMP is available, even to non-members of the society, at their webpage).   It is important to note that while DMPs are not regulated documents, they are in fact so commonly used across the industry they have become auditable, and therefore scrupulously close attention needs to paid to getting them right.

We outline 4 key points to bear in mind when creating or reviewing a Data Management plan.

Use a Standard Template for Consistency 

To a great extent, the DMP can, and should be standardized across projects for a consistent approach. When using a centralized biometrics model, where data services( data management, statistics, statistical programming) are conducted by a single provider, the development of such standard documents can represent an efficiency in the study set up, and also reduce the oversight burden for the sponsor.  Indeed, for any trial project, a robust Data Management Plan template provides a solid starting point.   One of the important challenges facing industry professionals today is the increasing complexity of clinical trials, and as such, great care needs to be taken to ensure the DMP accurately documents what actions will be taken with the trial data.  Having a highly experienced data management team working on your project, with a track record of implementing innovative and complex trial designs, therefore, becomes increasingly important in this environment. 

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Topics: Data Management, Clinical Research Services, outsourcing, Clinical Data, data manager


Adaptive Designs: A Data Management Perspective

Posted by Cytel

Oct 7, 2016 8:29:00 AM


Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success. While the principle is simple- to reduce the uncertainty in clinical development by obtaining additional information from the ongoing trial- the statistical methodologies can be complex, and expert support is often required to conduct the clinical trial design. There's also complexity in the data collection itself, so knowledgable data management support is needed to successfully execute an innovative trial design.  In this blog, we take a look at 5 top considerations for successful adaptive trial data management. 

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Topics: Data Management, Clinical Development Strategy, Clinical Data, Adaptive Clinical Trials, EDC, data manager, adaptive designs, adaptive trials


The CRO role in Data Standards Governance

Posted by Cytel

Aug 2, 2016 10:30:00 AM

As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance.  Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot topic in the industry and formed a substantial track at 2016’s CDISC EU Interchange back in April.

It has traditionally been common practice for biopharma companies to outsource their CDISC conversion of legacy data for the purpose of publications and submissions to expert CROs.  While large biopharma organizations may have dedicated in-house teams deployed to the management of standards governance, the dynamic nature of CDISC requirements means companies can struggle to find the resources to keep up to date and provide the best interpretation of the documentation. Outsourcing can be an option to ensure dedicated staff are available to manage and monitor these aspects and ensure companies remain submission ready.

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Topics: Data Management, Clinical Research Services, Statistical Programming, Clinical Data, EDC, database build, data manager, CDM, CDISC, SDTM, ADaM, CDASH


6 steps to timely database lock

Posted by Cytel

Jul 28, 2016 10:06:00 AM

To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a database if the data is not cleaned and you can’t have clean data unless you know what is most important for analysis. It’s imperative that data management works closely with the statistics group during CRF/ eCRF design to ensure data is being collected and data checks are being written in a meaningful fashion. But that’s still not enough. The data should be cleaned on a regular basis and forms locked as soon as the data has been SDVd and reviewed. Even then, it will be important to have your statistics team run listings and tables early on to catch anything unexpected. If the data is cleaned and locked by the time the last patient visit comes around then getting Principal Investigator sign-off and ultimately closing the database can run much more smoothly and quickly.

Database lock is a significant milestone in the clinical trial, upon which further data analysis and reporting timelines depend.  The Clinical Data Manager is responsible for steering the data management process to ensure that the database is locked on time, and correctly.  In this blog we lay out the 6 steps to database lock success.

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, big data


Key considerations in selecting an EDC system

Posted by Cytel

Jul 12, 2016 9:00:00 AM

 How do you go about selecting the best Electronic Data Capture (EDC) system for your study?  There is now a vast amount of choice in the market, and many factors to take into account before making your decision.  Different stakeholders within the business may also have different perspectives, so any decision making process needs to balance these disparate needs.  

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM


Overcoming Data Management Challenges in Oncology Studies

Posted by Cytel

Apr 26, 2016 11:30:00 AM

In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.  

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Topics: Oncology, Data Management, Clinical Research Services, Phase 1, Clinical Data, phase 2, EDC, database build, data manager, CDM, Biometrics


Handling CDM data integrations

Posted by Cytel

Apr 20, 2016 8:00:00 AM

During the course of any clinical trial, there are often data which, while collected electronically, are outside of the scope of the eCRF . These data include central lab results like ECGs, PK/PD data and others. In this blog we’ll take a look at some key considerations in handling electronic data transfers and any subsequent integration with the core EDC database.

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM


5 Key Interactions of Clinical DM and Statistics

Posted by Cytel

Apr 15, 2016 9:00:00 AM

It's critical for biostatistics and data management to be closely aligned and working effectively together. The consequences when these biometrics teams aren't integrated can be significant-  impacting on both efficiency and data quality.  If data is collected and cleaned without the input of statistics, the assumptions which have been made may not be adequate, resulting in additional work and compromised timelines.  So, let's take a closer look at 5 important interactions between the two functions during the course of a clinical trial. 

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Biometrics


Getting Technical: The evolving role of the Data Manager

Posted by Cytel

Feb 26, 2016 9:00:00 AM

Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time featured basic data entry screens, simple edit checks and a handful of reports. 

Technology has come a long way since then, and the EDC landscape has matured dramatically along with it.  Current EDC must-haves include easy user and site management, secure automated password retrieval, robust reporting, query and SAE management, as well as Source Data Verification, and Risk based monitoring. Many sites need to be active at the same time; labs need to enter or upload data directly into the system; medical coding should be performed inside of the tool; images need to be uploaded and stored; email and text alerts sent to investigators and sponsors, and patient reported outcomes and diaries need to be available.

Counter intuitively, while EDC system functionality is becoming ever more sophisticated, the interface to build the systems is becoming easier to use and understand.

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM


How to Make the Most of Data Management Capabilities for Improved Risk Based Monitoring

Posted by Cytel

Dec 1, 2015 3:00:00 PM

Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas, to maximize oversight of the most vulnerable data. The efficiency promised by RBM arises from the ability to detect the sources of data require the most attention, and distribute finite resources for oversight to the most problematic areas. This distribution aims to optimize attention on data sources which are in the most need of oversight, while decreasing attention on sources of data that have historically proven to be reliable.

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Topics: Data Management, Clinical Data, Risk Based Monitoring


The 24 Hour Work Day

Posted by Esha Senchaudhuri

Nov 5, 2015 3:34:15 PM

People Together-4

Oftentimes people perceive a tradeoff between speed and quality. The faster you do something the more likely you are to make mistakes. Then again, checking everything carefully means things take a longer time.

Right?  

What if you could promise a team that could work 24-7?

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Topics: Data Management, Clinical Research Services, Clinical Development Strategy


3 Statistical Challenges for Pooling Phase 1 Data

Posted by Esha Senchaudhuri

Oct 19, 2015 5:15:40 PM

It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of our clients have also begun to add Phase 1 safety data to this pool. On some occasions this is required by regulators. In many cases, however, these Phase 1 data simply provide further evidence that a new therapeutic lives up to the promise of safety across patient populations.

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Topics: Data Management, Safety, Early Phase Trials, Small Sample Sparse Data


Virtual Teams and Clinical Data Management

Posted by Esha Senchaudhuri

Sep 24, 2015 3:35:00 PM

Earlier this week, Patti Arsenault, Cytel’s Global Head of Clinical Data Management, sat on an SCDM panel with members of Gilead and Westat. The panel partook in an interactive discussion on both the opportunities and challenges which arise from managing virtual teams.

As teams become more global in nature – optimizing delivery by around the clock work hours –many have weighed in on the best way to manage virtual teams. Unfortunately, there seems to be very little agreement on such best practices. The panel provided insights from industry leaders in clinical data management, and then invited audience members to share their experiences.

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Topics: Data Management, Training and Education


Do you really need a full service CRO? An exploration of strategic options

Posted by Esha Senchaudhuri

Aug 13, 2015 9:00:00 AM

Full service or specialized? Full service or specialized?

For many looking to hire a CRO, the answer is obvious.

Obvious Answer #1: A full service CRO simplifies your life by ensuring you need only one point of contact in stressful situations or when things appear to be going wrong. Clearly you want a full service CRO because clearly you want to keep things simple.  
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Obvious Answer #2: A specialized CRO is exactly that, specialized. It sustains itself by being extremely good at doing the thing you hired it to do, and doing it better than everyone else. Clearly you want a specialized CRO because clearly you want the best.
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The decision is difficult in part because it touches upon various crucial points of a clinical trial sponsor's strategy: top-notch knowledge and expertise, timely delivery, simple responses to unforseeable events. Your business and development strategy should ultimately affect your decision-making. 

Here are a few things you might consider to avoid making a decision that is wrong for you. 

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Topics: Data Management, Clinical Research Services, Clinical Data


Building Teams to Handle Unexpected Regulatory Agency Requests

Posted by Esha Senchaudhuri

Jun 5, 2015 11:00:00 AM

Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received priority review status. Following submission, regulators requested that our client also submit pooled data from its Phase 1 studies along with a safety analysis. This analysis had the potential to clinch NDA approval for the new product.

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Topics: Data Management, Clinical Research Services, Regulation, Phase 1


How to Use Outsourcing to Reduce Clinical Development Risk

Posted by Esha Senchaudhuri

May 28, 2015 4:47:00 PM

Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development program at a time when regulatory standards are evolving, or competition is catching up with comparable products.

There is a particular source of risk, however, which deserves special attention. Currently, the pharmaceutical and biologics industry outsources approximately $25 billion dollars worth of clinical development projects. That is over a quarter of the $98 billion dollars currently devoted to clinical drug development.

This naturally raises several questions:

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Topics: Data Management, Clinical Research Services, outsourcing, Clinical Development Strategy


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