Company

Ticker Symbol

Product (s)

Phase Forward

PFWD

Inform ™ and ClinTrial™,

MediData

Private

Rave®

Title

Company

State

CRF and Database Design Specialist

Advanced Clinical Research Services

IL

President

Cross-Trained Data Professionals LLC

NY

Senior Director, Clinical Information Technologies

Theradex

NJ

Director of Clinical IT

KAI-Research Inc.

MD

Clinical Data Analyst IV

Gen-Probe

CA

Senior Manager, Clinical Data Management

Ascenta Therapeutics

CA

Manager Clinical Data Management 

Gilead Sciences, Inc.

CA

Associate Director, Clinical Data Management

Gilead Sciences, Inc.

WA

Manager, Clinical Data Management

PDL BioPharma, Inc.

CA

Question

Page number(s)

Q1: Awareness: Please list all companies you know of that produce electronic data capture software that is used to collect and store clinical trial data. Which of these companies’ products have you used for medical record storage?

4

Q2: Attributes: What are the key attributes of electronic data capture software that is used to collect and store clinical trial data (i.e., what do you look for in this type of software)?

8

Q3: Selecting software: What factors influence your decision to purchase one type of electronic data capture software over another? How do you ultimately decide among the different software that is available?

9

Q4: Competitive landscape: Please describe the strengths and weaknesses of electronic data capture software provided by: A) Phase Forward and B) MediData. If there are other major competitors, please list and discuss their strengths and weaknesses as well.

10

Q5: Trial phase: In what way does the phase of the clinical trial impact the decision to purchase one type of software over another (if any)?

14

Q6: Product pricing: What do you currently pay for electronic data capture software? For what features, if any, would you be willing to pay a premium over what you currently pay?

17

Q7: Next purchase: The next time you need to purchase new electronic data capture software, which software do you expect to purchase, when, and why?

18

Q8: New software: Are you aware of any new types of software for electronic data capture that may be coming to market in the next three years? If so, please list and indicate what impact you expect this new software to have on products that are currently available.

18

Q9: Offshore outsourcing: Do you expect the use of Indian or other offshore companies for electronic data capture or for the full CRO offering to change your need to purchase EDC software? Please explain the reason for your answer.

20

Q10: Other issues: What other issues or trends in clinical research may impact the market for electronic data capture software?

21

Instant survey

23

Panelist-initiated debate

24

Introduction

Welcome to this discussion among decision-makers at CROs. Our primary goal is to understand how you determine which electronic data capture software to use for clinical trials. MedPanel discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. Please note: In your participation on this panel, Panel Intelligence expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your Panel Intelligence home page after you've logged in.

Q1: Awareness

Please list all companies you know of that produce electronic data capture software that is used to collect and store clinical trial data. Which of these companies’ products have you used for medical record storage?

Panelist 1: ALMAC ClinPhone Datatrial Datatrak International DSG eClincialWorks eTrials e Research Technology Lambda Plus Medidata Phase Forward Phoenix Data Systems Trial Stat! Still in the process of picking EDC software for current company.

Panelist 10: In addition, there's Omnicomm.

Panelist 2: The companies I am aware of that have electronic data capture are (1) Study Manager, (2) Clinipace, and (3) Omnicomm. So far, I have used Study Manager.

Panelist 6: There are the following EDC Vendors: ALMAC (ICTI) OmniComm etrials Datalabs Medidata Phase Forward Oracle Clinical NexTrials Megasoft DSG Phoenix Data Systems DataTrak eRT Cmed Synteract ePRO vendors are: PHT CRF Inc. etrials IVRS vendors are: Quatern ALMAC Perceptive Informatics etrials Clinphone I have used the following EDC Vendors: etrials, DataTrak, ALMAC, OmniComm, Medidata I have used the following ePRO Vendors: PHT I have used the following IVRS Vendors: ALMAC, Perceptive Informatics

Panelist 2: You know what - I should have mentioned that one. Oracle has a remote data capture system. It is pretty efficient. But I would not use it if I was a small company that is trying to save money.

Panelist 7: eTrials DataTrak Medidata Phaseforward DataLabs

Panelist 7: I have forgotten Omincomm, DSG

Panelist 9: DataTrak PhaseForward Medidata Etrials Oracle NextTrials Health Decisions has a digital pen solution Clinical DataFax is a fax/paper based system that has developed an EDC solution that blends in. I personally have been involved with using- Medidata PhaseForward/inform The fax side of DataFax

Panelist 4: Lifetree Oracle eTrial Phaseforward KAI-Research OpenClinca

Panelist 4: Oracle Clinical

Panelist 4: Oracle Clinical Phase Forward KAI-Research Smart Study

Follow-up: Panelists 4 & 7

Thank you for listing the EDC products you are aware of; which of these, if any, have you used?

Panelist 7: eTrials DataTrak PhaseForward

Question to Panelist 7: Preferred system

Which EDC sytem did you prefer?

Panelist 7: I do not have a preference but I did like the DataTrak 4.0 interface better.

Panelist 4: Phase forward Lifetree Smart Study Older version of ORacle clinical before it was made for the Web.

Panelist 6: I have nothing additional to add here.

Panelist 9: Medidata PhaseForward/inform The fax side of DataFax

Panelist 3: I have on used my companies home-grown system

QUESTION TO PANEL: EDC system ratings?

I have a question for the moderator or anyone else on the panel related to this question. Is there a website that rates all of the EDC systems? I have never heard of etrial or Phase Forward.

Panelist 10: I have not heard of such a website.

Panelist 2: Well there should be one. Kind of like a consumer guide to EDC systems. I am amazed that there has n't been one. And a "winner" should be chosen every year as far as the best model for that year. Kind of like a car but EDC instead. Just my two cents.

Panelist 6: I agree too. It would at least be nice for each vendor to be listed with all their key attributes and specifications. Then, some you could eliminate right away and others you may never have heard of could be considered. Whenever I type EDC into google (or some variation of that word), I usually get the top 4 of have paid the most advertising. It's difficult to get at "ALL" the EDC vendors out there.

Panelist 2: Now that's interesting I will try that. Yes its unfortunate that we do not have access to a list of some sort...kind of like a consumer guide. I wish someone would start something like that. i would actually contribute to it from the users end.

Panelist 3: Oracle Clinical DataTrak

Panelist 3: Oracle Clinical Datatrak We have been using a homegrown system that has evolved for almost 20 years. We are currently considering migrating to Oracle Clinical

Follow-up: Panelist 3

You mention you are considering switching from the homegrown system to Oracle Clinical. What does Oracle Clinical offer that your homegrown system does not? What prompted the exploration to a potential switch?

Panelist 3: Our current system is lacking the reason for change to a record in the electronic audit trail. We use a paper trail to document this Our system is also not web enabled. We decided to finally switch because of the same findings external auditors have made.

Panelist 2: This question was for panel 3 but I would like to add that Oracle has a very powerful audit system, double data entry system, and change control. But its not as flexibl as the other systems. If you want to change database structure you have to answer to the audit trial which is like Fort Nox as far as I am concerned. For that reason, I have seen people not use Oracle to its full capacity because of all the audit protection it provides. Just being honest.

Panelist 4: If I can add something to this. It is difficulty for a company not specializing in software development to keep up with the evolving industry standards.

Panelist 7: I have not used Oracle Clinical for EDC Integration so I am not aware of this.

Panelist 6: I have nothing additional to add here.

Panelist 9: N/A

Panelist 3: We have also looked into OpenClinica. Even though it is open source and free to use, we were required to pay a developers fee for the code. We also were required to share and updates we made, but that would have been a problem

Follow-up: Awareness

What is the main source of awareness of these products?

Panelist 3: Industry publications, conferences, and vendor solicitations

Panelist 10: Industry publications, conferences, word of mouth, internet searches, CROs, and mailings.

Panelist 1: Internet, word of mouth, industry related publications

Panelist 2: conferences, exhibitions at conferences, advertisements in journals

Panelist 4: Personal use Advertisements Meetings

Panelist 1: Internet, word of mouth, industry related publications

Panelist 7: I think many people do not necessary know all the products that are available. DIA is a good place to present this but at the same time there is too many things going on and people trying to sell you something. I think in small conference you are more likely to attract attention.

Panelist 6: I have learned about various EDC vendors from: *SCDM Conference *DIA Conference *Advertisements received for Webinars *Doing Google searches on EDC applications and then having Demos *Talking with colleagues at various companies *Contacting CROs and doing a RFI on what vendors they use

Panelist 9: Conferences Vendor contact/advertising Web/network research

Panelist 8: In addition to the channels mentioned, a recommendation from a trusted collegue is influential.

Follow-up: Multiple products

Several panelists mention using more than one system. If you use more than one, why do you need multiple products? If you have switched from one to another, please indicate what prompted the switch.

Panelist 10: We use one product mainly but have recently merged with a company that uses two other products. Often, you will also have your main vendor but do one-off projects with other vendors either to try new products or due to differences in study design (e.g. the need for DDE, randomization, etc.)

Panelist 7: We want to do a comparison to see which product meets our need. At the end of the day, we would like to focus on 2 vendors. Having multiple vendors consume a lot of time during setup and building a standard library dictionary.

Panelist 3: The CRO I work for could only afford one system. If we were able we would use multiple systems in order to have the preferred system of our clients.

Panelist 2: I have been on the Sponsor end where we are shopping for a CRO. A lot of times a company might not work with you if you do not know how to us their preferred product. It just helps to be knowledgable.

Panelist 4: I basically use one product, but sometimes the client has their own or one that they purchased and they want us to use that one.

Panelist 1: We are looking at having 2-3 systems so that we always have a system that will accomodate the needs/preferences of our clients.

Panelist 8: Since purchasing eResearch Technology, we are only using it on future studies. We do, however, have a current study which will continue at least 3 years. When we have time, we will look into bringing the legacy study into the new system.

Panelist 6: We decided to pilot on 2-3 different EDC applications, so that we could have experience with and pick who we felt would be able to take us through the long haul (an international phase III NDA trial). Until then, we wanted to get experience, as each vendor has been a completely different experience! However that said, we do want to find just one vendor so that we can start realizing the efficiencies of startup: having standard crfs, specifications, edit checks, global libraries, etc. We also hope to be able to do a tech transfer and build our internal capabilities once we choose one vendor. We have given each vendor several studies, so that we test that one study's occurrences wasn't just a fluke. So far that has proved true. The bad that happened on one, has continued to happen on the other.

Panelist 9: We have one main non-EDC data management system in-house. We're running studies through CROs to test out different EDC systems.

Panelist 8: We issued an RFP to Netregulus Life Tree eClinical Data Trak Medidata eResearch Technology Phase Forward Oracle Pharmaceuticals DataLabs Phoenix Data Systems Omnicom We bought and are using eResearch Technology.

Panelist 7: We did you a homegrown system once...Registrat. It was not the best software, many issues with homegrown software.

Panelist 7: Same as above

Panelist 7: Registrat we've used and it was not a good system.

Q2: Attributes

What are the key attributes of electronic data capture software that is used to collect and store clinical trial data (i.e., what do you look for in this type of software)?

Panelist 2: I look for a system that has an audit trail, simple trial set-up features, flexible data capture screens and data validation features, and version control capabilties.

Panelist 2: Ability for the data to be uploaded into a statistical software package. Ability for data to be imported from an external source, such as ECG or lab data.

Panelist 6: I look for a system that: Is user friendly Can be accessed by any browser and little system requirements, no additional hardware Can handle complex visit schedules Can handle dynamic fields, forms, and visits Can handle log type date entry forms Can also function as a paper data entry system Can handle local lab normal ranges Can handle coding of AEs and Conmeds Has a flexible workflow (i.e. roles, responsibilities, status icons for: SDV, Monitor Review, Data Manager Review, Freezing, Locking) Is CRF Part 11 Compliant and is validated Can provide real-time download access to the data Has various data listing and metric report capabilities Can be built using sponsor variable standards

Panelist 7: I look for unscheduled visits, audit trails, CFR Part 11 Compliant, easy mid-study changes, not too many out of scope cost, online training and easy on the eyes software.

Panelist 9: Ease of use for clinical sites is the top priority. Compliance with all necessary regulations-audit trail, user authentication, electronic signature, etc. Ability to setup forms/visits the way we need to for our studies. Ability to setup user roles and workflows Tracking of monitor activites, lock/freeze by page or subject. Standard real-time edit checks that can do complex across form checks.

Panelist 4: 1. Fast response 2. Good Screen creation functionality 3. Easy to set a visit schedule 4. Easy to write custom edits - particularly important in government clinical trials 5. Easy to interface with SAS 6. Good battery of reports and good report generator

Panelist 3: Part 11 compliance Industry accepted Integrated data management systems Easy set-up

Panelist 10: There are core attributes and then your own needs. Core attributes: CFR Part 11 compliance Cost Financial stability of the company Hosting capabilities Interface/ease of use Future plans for company and product How are mid-study changes handled Flexibility of product How are contracts structured (i.e. do they charge by license, by user, by datapoint?) Customer base and customer service (Most important for small companies) Your needs: Double-data entry for paper forms Do they offer a knowledge/tech transfer model or only ASP? Do you have previous experience with the vendor? What type of integrations might you need and can they handle these tasks? How do you get your data? Is the format flexible? Can you retrieve your data on demand and is it real time data or a saved view? What level of help desk support do they offer?

Panelist 1: * Flexibility - can the tool be modified to meet our needs * Training and Certification * User Friendly * 24/7 Tech Support * Real time data and reporting * Customizable reports * Direct programming of the tool * Study set-up able to be performed in house * SAS datasets * Exportability/interaction with Oracle Clinical * Subsystem compatibility - coding, lab normals, AERS * Blinding * Cost * Uploading of lab/diagnostic reports

Panelist 8: My company manufactures and sells diagnostic products. Although quite a few companies responded to our RFP, only 3 came to us to run through the demo script we had compiled. Of the 3, only 2 came close and the one we selected had devised ways to work through their system to handle our unique needs.

Q3: Selecting software

What factors influence your decision to purchase one type of electronic data capture software over another? How do you ultimately decide among the different software that is available?

Panelist 2: I think that it depends on your working environment. Some facilities are only concerned with whether or not the system can capture the data accurately. Other institutions (with more money) may want to ensure that the system can generate a lot of fancy reports. Personally, I would pick the system that is the least complexed in terms of trial set-up. But at the same time, the system should have my basic requirements.

Panelist 7: Usability, easy to design, easy access and reliability. I do believe project management is very important as well

Panelist 9: Most of the products available meet the minimum requirements. My current company is investigating bringing in an EDC system. We've tested a couple by running studies through full-service CROs. Main criteria is ease of use at sites and cost, then ease of use on our end.

Panelist 4: 1. Features 2. Price 3. Support 4. Easy of use

Panelist 3: Easy start-ups Initial cost and per study costs Industry accepted

Panelist 10: The vast majority of these vendors are similar in the features that they offer. (This is becoming more and more true each year.) Find a company that has not only a product that suits your needs but that you can also work with closely. Smaller companies may want to choose a vendor that is also smaller so that you get the attention that you need. If you have one study and the other clients that they service have over 100 studies each, the level of service you get will probably not be adequate. Also, make sure to compare like costs when looking across vendors. Most of them bid quite differently, so it is difficult to compare bids.

Panelist 6: We look for: User-friendly, eye-pleasing, looks like the other common websites out there so non-technical people won't get confused Features that work with the complexity of our studies and our workflow processes Easy access to data, via on-demand downloads and useful reports Technically robust, in that it can be used with any browser, any computer, in any country The vendor has experience in the therapeutic area, the countries desired, and their references all check out along with word of mouth experience It has additional capabilities like double data entry, coding, IVRS, imports of data That cost is inline with the other bids we are receiving and not too low or too high

Follow-up: Importance of attributes

Panelists listed the following as important attributes in selecting software: a. Captures data for even most complex studies b. Sophisticated report generation (more important to some) c. Least complex, easiest to set up and use, easy on the eyes d. Project management tools e. Universality: by country, computer type, browser type f. Cost g. Industry accepted h. Manufacturer: good service, matching needs, therapeutic expertise, good references What are the top two most important attributes in selecting EDC software, in your opinion, and why?

Panelist 3: Being a small CRO...cost and industry accepted would be the top 2.

Panelist 6: Now that we have piloted with a few EDC Vendors, I would say the most important factors are: Experience and Overall Satisfaction But, if I was choosing for the first time again, I would say: Experience - references, word of mouth from colleagues, audit findings Ease of Use for the sites, DM, and internal folks that correlates with current workflow processes

Panelist 10: c) Ease of use for end users. If the end user hates the system, then they won't enter data or may enter it inaccurately, which negates the advantage of quick entry and real-time data review. f) Cost. If the cost is off the chart or the return on investment is not where it needs to be, Sr. Management at any organization will have a hard time supporting the initiative/vendor.

Panelist 7: C, H

Panelist 2: A, C

Panelist 4: Industry accepted Easy to use

Panelist 1: Ease of use and sophisticated report generation.

Panelist 9: C - Ease of use on clinical site side is top. All EDC advantages are lost if sites can't/don't like to use F - Cost. That's where my compant is really balking at moving the EDC

Panelist 1: We are currently in the process of selecting our EDC system. Key things we are looking for are flexibility, training, support, and how well it meets our overall needs.

Panelist 8: As I stated previously, we had a number