Cidar provides services spanning from high level strategic consulting to day to day on site project management.
"Our company has grown very quickly and our IT infrastructure now needs to cover a full development organization."
Balancing in-house and in-sourced services of a growing company requires a good road map for the IT department. Supporting the functions of a growing development organization requires vertical application know-how, but also a solid infrastructure for collaboration, security and remote access.
"Our European based company wants to reach new customers in the United States. How can we build credibility and trust with this audience?"
The pharmaceutical and biotech industries are people businesses. Trust, quality, and ability to deliver are major components in all buying decisions. You build trust by demonstrating your expertise to prospects. Workshops and tutorials can be an excellent forum to build recognition and establish yourself with your clients.
"We need to improve the efficiency of our teams and set up structures to better access project team knowledge."
Cidar works with your team to improve project management structures and implements tools to better enable team communication.
"We urgently need support for our project management team."
Cidar provides an immediate "plug and play" solution if you are short of project managers. We also help to manage peak time before IND or NDA filing , Pre-Approval Inspection etc.
"We need a dashboard that tells management the up to the minute status of each projects."
Cidar has developed dashboards that enable a bird's eye view on projects without requiring additional work from the project teams.
"We have data from several different trials and a variety of CROs. How do we consolidate the data to get ready for submission?"
While your company might outsource most study operations to CROs, you will have to bring the data in-house for analysis, archival or submission. We help you develop such a data repository based on existing data management or statistical systems, or as central data warehouse incorporating current standards such as CDISC ODM, SDM, and ADaM.
"Our oncology team is running very complex protocols which demand clean data almost in real time. Our organization currently cannot handle these time pressures."
Advanced trial methodology such as Adaptive Trials Designs
requires data in almost real time. While EDC technology provides the
basis for faster data capture and review, we will work with your team and
partners to provide the correct processes, training, and incentives
to actually realize the technology's potential.
"We just do not have the staff to run a full requirement analysis, select vendors, and then implement and validate a new system."
Cidar runs the complete process from requirements analysis, request for information, request for proposal, vendor selection, contracting, implementation and validation for industry solutions.
"We are doing due diligence and in-licensing. How can we control the document flow?"
Cidar provides an efficient system and tools to help you through due diligence efforts for either financing or partnering purposes, leaving your scientist and management to do their job.
"We need to exchange information quickly and securely with our global team and quite a number of external development partners."
Cidar designs document management and collaboration tools for workgroups in secure yet accessible environment.
"We need to control SOP versions, distribution and training documentation."
Cidar develops document management and workflow solutions to suit your processes or we can provide a turn-key solution for SOP management.
"We would like to organize our records to get ready for an eCTD submission."
Cidar can propose a document and record management solution based on the emerging document concept and the eCTD requirements to get your records in order for an electronic dossier. This solution covers the ongoing record keeping prior to the actual dossier compilation and publishing.
"We have a myriad of external and internal information. How do we distribute what is relevant?"
Cidar works with the client on efficient collaboration tools such as team blogs and wikis to collect, publish, and annotate relevant information in the enterprise. A change in incentives might be necessary too: "Publish or Perish" does no longer apply to academics only.
"How do we integrate modeling and simulation techniques in our development process? What consequences will this have on our data needs and processes?"
Models are an expression of knowledge and fitted with data provide a good basis for forecasting and decision making. If the organization chooses such a quantitative approach various changes will become necessary: Starting with increased requirements for speed and volume of data, training and education will become crucial elements for the successful application of these advanced methodologies.
"Our organization wants to move beyond ad hoc decision making to a well defined decision framework with clearly specified decision criteria and information needs."
Cidar helps the client implement an "Emerging Decision Framework" that links each decision to the underlying information source in the enterprise and updates decision makers when such information becomes available.