DSP

DSP is a full service CRO that manages Phase I-IV clinical studies for small to mid-sized pharmaceutical, biotech, and device companies from study setup through NDA submission.

Services

Study Management

DSP Study Management services range from comprehensive management of the entire study to management of only parts of the study.

As clinical trials and study protocols become increasingly complex, we can meet your most demanding study requirements and take on as much of the study planning as you need. We work closely with you from project onset to make sure we fully understand your goals, timeline, budget and expectations.

We are confident about our tested processes, yet we are not afraid to use creative approaches and out-of-the-box thinking when new challenges arise.

Study Management services include:

  • Study Start-Up
  • Vendor Selection and Management
  • Study Maintenance
  • Study Close-out

What DSP Can Do for Your Study

Task DSP Partner company
Protocol development, review, comments X  
Investigator identification and selection (initial contact, obtain CV, secrecy agreement, evaluate credentials) X  
Distribute protocol and questionnaire to sites X  
Perform pre-study site visits X  
Evaluate pre-study visit reports and final selection of sites X  
Investigator contract and budget negotiations X  
Collection of regulatory documentation from sites (CVs, licenses, 1572, financial disclosures & IRB approval) X  
IRB submission/management X  
Obtain proposals from outside vendors (central laboratory, IRB, etc) X  
Interview and conduct site visits to outside vendors being considered X  
Contract and budget negotiations with vendors and finalization of specifications X  
Prepare and finalize study documents (site and monitor specific operations manuals, case report form, informed consent and other site documents) X  
Order clinical supplies and coordinate and track initial shipments to sites X  
Set-up study files (regulatory binders, training manuals & trial master file) X  
Investigator meeting (setup, binders, etc) X  
Lead study team meetings with internal/external team members from study start to final clinical study report X  
Study monitoring (pre-study, initiation, interim, final visits) X  
Site Auditing (DSP will randomly visit sites to audit monitor and investigator performance) X  
Monitor and site training X  
SAE management and tracking X  
Provide weekly status reports on subject enrollment, spending, grant payments, site/monitoring/vendor issues X  
Continuous site management (tracking and collection of regulatory documents, IRB approvals & drug shipments) X  
Outside vendor management (monitoring of vendor activities to ensure contract specifications and tracking and payment of contract/milestone payments) X  
Tracking of enrollment, timelines and budget X  
Setup and maintain and manage trial master file X  
Coordinate/manage data management, statistics, medical writing, regulatory on a routine basis from study start to clinical study report X  
Data management (database set-up, CRF development, programming, queries, datalock) X  
Continuous review of CRF data, AE tables and other safety tables X  
Statistics (analysis plan review, tables/listings, etc)   X
Medical writing (prepare and finalize clinical study report)   X

Morris Corporate Center 1, 300 Interpace Parkway, Bldg C, Parsippany, NJ 07054 • P: 973-265-1060 F: 973-402-0880