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Last Post: 1/22/2019 6:19:26 PM - Followers: 76 - Board type: Free - Posts Today: 0

Biocept, Inc., headquartered in San Diego, California, is a commercial-stage oncology diagnostics company focused on providing information on patients' tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA or ctDNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers its OncoCEE-BRTM test for breast cancer and OncoCEE-LUTM for non-small cell lung cancer and OncoCEE- GATM for Gastric Cancer and plans to introduce additional CLIA validated tests for breast, lung, colorectal, melanoma, prostate and other solid tumors based on its proprietary technology platforms over the coming months.



 

The Leader in Clinical Trial Management Solutions

BioClinica accelerates the development of new medical therapies by delivering expertise and technologies that enhance clinical research, worldwide. Our industry-leading Medical Imaging services, Cardiac Safety, and enterprise eClinical platform bring a new level of quality and efficiency to every phase of clinical development. Our experience spans three decades and includes thousands of studies in all therapeutic areas, from design and management, through submission and post-approval. BioClinica serves more than 400 pharmaceutical, biotechnology, and device companies – including all the top 20 - through a network of offices in the U.S., Europe, and Asia.

 
 

IRT Sourcing Models, Breaking with Convention (Part 2)

Submitted by Steve Goldstein on February 18, 2015 - 4:34pm

What Makes an IRT Great for Technology Transfer?

In the last blog we talked about how technology transfer is gaining ground on the conventional Software as a Service (SaaS) IRT sourcing model. In this blog post, I will explain the advantages of the technology and design behind Trident that make it particularly well-suited for IRT technology transfer. So let's dive right in.

IRT Sourcing Models, Breaking with Convention (Part 1)

Submitted by Steve Goldstein on February 18, 2015 - 4:02pm

Technology Transfer Gaining on Saas

When it comes to Interactive Response Technology (IRT) – systems used to perform subject randomization, drug dispensing and study drug resupply – Software as a Service (SaaS) continues to be the conventional delivery model including here at BioClinica.

Key Insights from SCDM Euro Leadership Forum

Submitted by Jonathan Andrus on February 6, 2015 - 4:15pm

Break-out Group Dissects the Development of a Risk-Based Approach To Clinical Trial Management

As SCDM's 2014 Chair I had the honor of presenting the keynote at the EU Leadership Forum held in The Netherlands, December 2014. Celebrating the organization's 20th Anniversary and all that's been accomplished, we took a light-hearted look at the Evolution of the Clinical Data Management Role.

Escalating Role of Medical Imaging in AD Clinical Trials

Submitted by Eli Berdougo on January 30, 2015 - 1:12pm

Studies Reveal Impact of Implementing, Standardizing, and Developing Neuroimaging Endpoints in Alzheimer's Disease Trials

Alzheimer's disease is one of the most important health challenges facing aging populations worldwide. Disease modifying therapies are desperately needed and many potential treatments are currently being tested in clinical trials. The role and impact of medical imaging in AD trials continues to grow, especially as clinicians and scientists seek to define and treat AD at the earliest stages of disease.

Risk-Based Monitoring Technology: 5 Essential Capabilities

Submitted by Courtney McBean on January 27, 2015 - 2:05pm

If you've spent time researching risk-based monitoring (RBM) over the past year, you know dozens of academics, CROs, clinical trial practitioners, and statisticians have proposed varied approaches based on sponsor needs and trial designs. Unfortunately, despite an abundance of theoretical perspectives on RBM, clinical trial teams soon discover a significant gap still exists between perspectives and actual tools to enable real-world RBM implementation.

Time to Take Action and Make Risk-Based Monitoring a Reality

Submitted by Courtney McBean on January 19, 2015 - 12:23pm

Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.

What’s New with CDISC Standards?

Submitted by Jennifer Price on December 16, 2014 - 11:13am

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

Evolution of the Clinical Data Management Role, 1994-2014

Submitted by Jonathan Andrus on December 9, 2014 - 12:11pm

20-Year Retrospective

The role of the Clinical Data Manager (CDM) has changed immensely since 1994, both in terms of role and function. Let's take a fun retrospective look at the great strides made in our field over these last 20 years, and more importantly, where the CDM role is headed. Let's begin with 1994, in honor of the Society of Clinical Data Management (SCDM), which commemorated its 20th Anniversary in 2014.

3 Reasons to Share Data from Unsuccessful Clinical Trials

Submitted by Eli Berdougo on November 25, 2014 - 4:53pm
3 Reasons to Share Data from Unsuccessful Clinical Trials

A recent proposal by the U.S. Department of Health and Human Services (HHS) could expand the amount of clinical trial data that drug companies must share with the public. Under the proposal, clinical trial sponsors would be required to report findings for drugs and devices that fail to reach approval.
 

eSource: Are You On-Trend with Other Sponsors?

Submitted by Jennifer Price on November 12, 2014 - 11:17am

eSource is a topic that has everyone talking and it continues to dominate the conversation at industry gatherings, including the annual SCDM conference held earlier this fall. From what I heard there − and continue to hear – sponsors' experience with eSource runs the full gamut.

Why 'Intelligent Monitoring' Is Even Smarter than Risk-Based Monitoring

Submitted by Courtney McBean on October 31, 2014 - 1:27pm

When I speak on the topic of risk-based monitoring (RBM) at industry events, someone invariably comes up afterward to say how nice it is we finally stopped talking about risk-based monitoring!

eSource: Still in the Shallow End of the Pool?

Submitted by Jennifer Price on October 23, 2014 - 3:25pm

Dipping a toe in the water is always easier than jumping right into something new.

I am reminded of this old axiom as I look back at the recent SCDM conference and see it holds true for eSource.

Testing different eSource modalities within a controlled environment is one way to get acclimated and explore the use of eSource in your clinical trials while building experience – all in a low-risk way. Beginning with data that's directly entered as eSource is a whole lot easier and safer than attempting to hit it 100 percent from the high dive on the first try.

7 Principles of eSource Use

Submitted by Jennifer Price on October 17, 2014 - 10:31am
7 Principles of eSource Use

As I write this, I’m on a return flight home to Philadelphia from Las Vegas where I attended the Annual SCDM conference. It was a great event and I’m pretty revved up to share what I saw and heard there, especially on the evolving topic of eSource.

One session I’d like to tell you about is an eSource roundtable that was moderated by Linda King, Director of Global Data Delivery at Eli Lilly and Demetris Zambas, VP and Global Head, Data Management at Novartis. Representatives from CDISC, Merck, J&J, AssisTek, Quintiles, and Otsuka rounded out the expert panel.

Response to TransCelerate’s Risk-Based Monitoring Paper: Technology Considerations to Enable Risk-Based Monitoring Methodology

Submitted by Courtney McBean on September 30, 2014 - 1:46pm

Have you had a chance to read the latest TransCelerate paper on risk-based monitoring (RBM)?

If not, I highly recommend getting your eyes on Technology Considerations to Enable the Risk-Based Monitoring Methodology, published online in August on behalf of the Drug Information Association (DIA). This paper serves as a tremendous resource for any organization interested in new enterprise technology to help realize the advantages of risk-based monitoring.

Highlights from the 2014 Osteoarthritis Imaging Workshop

Submitted by Eli Berdougo on September 23, 2014 - 2:58pm
Highlights from the 2014 Osteoarthritis Imaging Workshop

This summer, experts from academia, industry and regulatory sectors gathered in Reykjavik, Iceland for The International Workshop on Osteoarthritis Imaging (IWOAI) to discuss the latest advances related to imaging in Osteoarthritis (OA). Presentations at this conference centered on new imaging techniques and analytical methods for monitoring OA pathophysiology and evaluating imaging data from clinical studies.





 
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BIOC News: Current Report Filing (8-k) 01/18/2019 04:52:57 PM
BIOC News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 01/18/2019 04:42:49 PM
BIOC News: Statement of Ownership (sc 13g) 01/18/2019 04:30:39 PM
BIOC News: Biocept Announces Pricing of $2.2 Million Registered Direct Offering 01/18/2019 09:00:00 AM
BIOC News: Amended Statement of Ownership (sc 13g/a) 01/03/2019 02:59:29 PM
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#1738   I was waiting for $1.60 Kid-Gloves 01/22/19 06:19:26 PM
#1737   Back In 1.88 Lets see !!! Animas 01/22/19 01:31:48 PM
#1736   Thanks Clay Been a big week here. Animas 01/17/19 07:08:46 PM
#1735   * * $BIOC Video Chart 01-17-2019 * * ClayTrader 01/17/19 05:56:11 PM
#1734   Carl Icahn just took stake today Biggeoff 01/17/19 03:46:37 PM
#1733   Another strong day. Something big is up. when Animas 01/17/19 02:27:04 PM
#1732   fasten your seatbelts ladies and gent. We are aristotelisonassis 01/17/19 02:02:26 PM
#1731   one hour chart showing 3.34, if it breaks Animas 01/17/19 11:56:53 AM
#1730   May buy in again if it retests 2nd support Kid-Gloves 01/17/19 11:51:12 AM
#1729   I bought at 2.70 sold @ 3 Kid-Gloves 01/17/19 11:50:11 AM
#1728   Impressive Break of $3.00.Chart says we are going higher. Animas 01/17/19 11:31:22 AM
#1727   * * $BIOC Video Chart 01-16-2019 * * ClayTrader 01/16/19 05:19:42 PM
#1726   Will be watching BIOC closely tomorrow since it nokomis 01/16/19 05:18:26 PM
#1725   Wild ride today !!!! Animas 01/16/19 03:26:28 PM
#1724   Looks heavy now , should see a sharp Kid-Gloves 01/16/19 12:08:18 PM
#1723   Not sure what's driving it , I sold Kid-Gloves 01/16/19 12:03:24 PM
#1722   News driven here ?? Hawkeye_tt 01/16/19 12:00:24 PM
#1721   So what happened here today, what was the news TAB78 01/14/19 08:12:38 PM
#1720   $BIOC Trader's Cheat Sheet Golden_Cross 01/14/19 04:45:08 PM
#1719   * * $BIOC Video Chart 01-14-2019 * * ClayTrader 01/14/19 04:40:21 PM
#1718   Sold too early Kid-Gloves 01/14/19 04:03:51 PM
#1717   Going going hopefullly Satchels 01/14/19 03:29:50 PM
#1716   Triangle pattern again , about to shoot north Kid-Gloves 12/26/18 11:05:23 AM
#1715   Loading at .80 and up now Kid-Gloves 12/24/18 11:46:52 AM
#1714   Should see $1 today Kid-Gloves 12/21/18 10:03:55 AM
#1713   Beautiful load under .80 Expensivetaste281 12/21/18 09:47:23 AM
#1712   Buy buys Kid-Gloves 12/21/18 09:38:55 AM
#1711   I'm not worried . If you bought at Kid-Gloves 12/20/18 09:07:33 PM
#1710   Unfortunately this company is wearing baby gloves. Pickles1109 12/20/18 08:59:50 PM
#1709   Goingnover $1 tomorrow . Kid-Gloves 12/20/18 07:07:36 PM
#1708   1 tomorrow going to be fun. Inching back Kid-Gloves 12/20/18 04:26:39 PM
#1707   Yep big volume now . Mm loaded 80-85 Kid-Gloves 12/20/18 02:58:35 PM
#1706   Too easy , $1+ tomorrow Expensivetaste281 12/20/18 02:57:50 PM
#1705   Triangle pattern forced push north Kid-Gloves 12/20/18 02:56:25 PM
#1701   #3 on breakouts . Should hit pre offering Kid-Gloves 12/20/18 10:43:45 AM
#1700   Second wave up could be starting Kid-Gloves 12/20/18 10:40:27 AM
#1699   Looks like profit taking bottom . We should Kid-Gloves 12/20/18 10:36:52 AM
#1698   With the updated book value as of today Kid-Gloves 12/20/18 10:26:15 AM
#1697   WEEEEEEEEE Expensivetaste281 12/20/18 10:20:42 AM
#1696   Get ready for lift off Kid-Gloves 12/20/18 10:16:33 AM
#1695   $2.40's Updated BOOK VALUE!!!! $$$$$ BOOM!!!! ALL-IN888 12/20/18 10:16:15 AM
#1694   Heavy buying pressure could send us up another .15 Kid-Gloves 12/20/18 10:14:37 AM
#1693   Bigger move lining up soon ///M3 12/20/18 10:14:04 AM
#1692   Green Lets Go!!! $$$ ALL-IN888 12/20/18 10:11:34 AM
#1691   Yeah I bought more @.72 ALL-IN888 12/20/18 10:05:31 AM
#1690   So triple 8? you still in? I thought HomieTheClown 12/20/18 09:57:10 AM
#1689   Read my posts!!! They need to be loading ALL-IN888 12/20/18 09:46:34 AM
#1688   So how is that working out for you? longboarder7892 12/20/18 09:44:13 AM
#1687   So much selling Imarket13 12/20/18 09:33:26 AM
#1686   I’ve been waiting for it should bounce here ///M3 12/20/18 09:32:01 AM
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